BD BBL¿ VENTING UNIT
Received Apr 8, 2026 · Event occurred Mar 10, 2026
Report 1119779-2026-00619 · MDR key 24815122
Device
Generic name
Monitor, Microbial Growth
Manufacturer
Becton, Dickinson & Co. (sparks)Catalog number
271056
Lot number
241103
Product problems
- Filling Problem
- Product Quality Problem
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING AN UNSPECIFIED NUMBER OF BD BBL¿ VENTING UNIT, THE CUSTOMER STATED THAT THE DEVICE HAS BEEN PROBLEMATIC FOR SOME MONTHS, IT CLOGS WHEN USED. THE USER HAD TO CHANGE THE DEVICE SEVERAL TIMES TO GET A DROP OF SAMPLE AND THE PROBLEM ONLY OCCURRED ON BLOOD CULTURE BOTTLES WITH RESIN. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.