FDA Adverse Event
Malfunction
Summary report: N
BD BBL¿ DRY ANAEROBIC INDICATOR STRIPS
MDR report key: 24887948
·
Received April 15, 2026
Report
- Report Number
- 2647876-2026-00025
- Event Type
- Malfunction
- Date Received
- April 15, 2026
- Date of Event
- March 25, 2026
- Report Date
- May 1, 2026
- Manufacturer
- BECTON DICKINSON CARIBE LTD.
- Product Code
- KZJ
- UDI-DI
- 30382902710517
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 · 0
IT WAS REPORTED THAT WHILE USING BD BBL¿ DRY ANAEROBIC INDICATOR STRIPS, THE CUSTOMER NOTICED SOME OF THE INDICATOR STRIPS ARE NOT TURNING WHITE AFTER BEING PLACED IN THEIR LARGE GASPAK EZ CONTAINER, AND OTHERS TAKES LONGER FOR THEM TO TURN WHITE ON UNSPECIFIED NUMBER OF PATIENT SAMPLES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 347351 | BD BBL¿ DRY ANAEROBIC INDICATOR STRIPS | DEVICE, GAS GENERATING | KZJ | BECTON DICKINSON CARIBE LTD. | 5329942 | 30382902710517 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |