K982541

Substantially Equivalent

VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 368607 & 368608

Applicant: Becton Dickinson Vacutainer Systems
Product code: FMI
Advisory panel: General Hospital
Date received: 1998-07-21
Decision date: 1998-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin Lake, NJ, US

Adverse events under product code FMI

product code FMI

Death: 28
Injury: 1,517
Malfunction: 23,981
Other: 18
Total: 25,544

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.