K033576

Substantially Equivalent

LIFESHIELD LATEX-FREE PRIMARY IV PUMP SET DISTAL MICROBORE PATIENT LINE, CONVERTIBLE PIN, 72 INCH, WITH 2 PRESSURE

Applicant: Abbott Laboratories
Product code: FPA
Advisory panel: General Hospital
Date received: 2003-11-13
Decision date: 2003-12-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Abbott Park, IL, US

Adverse events under product code FPA

product code FPA

Death: 95
Injury: 14,421
Malfunction: 125,815
Other: 30
Total: 140,361

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.