K151866

Substantially Equivalent

BD BACTEC Peds Plus/F Culture Vials (plastic)

Applicant: Becton, Dickinson and Company
Product code: MDB
Advisory panel: Microbiology
Date received: 2015-07-09
Decision date: 2016-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sparks, MD, US

Adverse events under product code MDB

product code MDB

Death: 6
Malfunction: 5,490
Total: 5,496

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.