K051194

Substantially Equivalent

BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER, MODELS 384647, 384667, 384687, 384648, 384668, 384688, 384649, 384669

Applicant: Becton, Dickinson & CO
Product code: LJS
Advisory panel: General Hospital
Date received: 2005-05-10
Decision date: 2005-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sandy, UT, US

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Adverse events under product code LJS

product code LJS

Death: 31
Injury: 2,791
Malfunction: 18,374
Other: 5
Total: 21,201

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.