title: Complications associated with central venous catheters. A survey.
abstract: The Federal Food and Drug Administration has a system for reporting problems with medical devices that requires manufacturers of medical devices to report medical complications or equipment malfunction that causes, or could cause, death or serious injury. In a two-year period, central venous catheters were associated with 170 complications: tissue perforation, loss of catheter integrity, (including: catheter separation, severance, break, rip, puncture, or leak), and other problems. Causes of the complications were related to device failure (12 percent), health care professionals (55 percent), patients (3 percent), or pathologic or physiologic aspects (3 percent); causes of 28 percent of the complications were indeterminable. Further analysis indicated that complications (especially tissue perforation) were primarily health professional technique-related. There were no reports of complications related to infection. Data support the need for more education in catheter application and the need to modify the system by which these data are reported to more reliably detect infection.
authors.affiliation: Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD.
authors.forename: W L
authors.initials: WL
authors.lastname: Scott
mesh_terms: D002405:Catheterization, Central Venous / Q000009:adverse effects / Q000295:instrumentation*; D004868:Equipment Failure; D006280:Health Workforce; D006801:Humans; D007256:Information Systems; D014481:United States; D014486:United States Food and Drug Administration