BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC)
Report
- Report Number
- 2647876-2026-00009
- Event Type
- Malfunction
- Date Received
- February 16, 2026
- Date of Event
- January 22, 2026
- Report Date
- March 3, 2026
- Manufacturer
- BECTON DICKINSON CARIBE LTD.
- Product Code
- MDB
- UDI-DI
- 00382904420208
- PMA / PMN Number
- K151866
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION. DATE RECEIVED BY MANUFACTURER: 03-MAR-2026. AFTER FURTHER EVALUATION OF THE COMPLAINT AND THE INVESTIGATION, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 2647876-2026-00009 WAS SENT IN ERROR. THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION, OR REPORTABLE DEVICE MALFUNCTION. THEREFORE, THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.
THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G4. PMA / 510(K)#: K173873 A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED WHILE USING BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC), THE LABEL INFORMATION LISTED ON ONE BOTTLE WAS INCORRECT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER AT THIS TIME.
IT WAS REPORTED WHILE USING BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC), THE LABEL INFORMATION LISTED ON ONE BOTTLE WAS INCORRECT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 186824 | BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) | SYSTEM, BLOOD CULTURING | MDB | BECTON DICKINSON CARIBE LTD. | 5135314 | 00382904420208 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |