BD BBL¿ VITAMIN K1 - HEMIN SOLUTION
Report
- Report Number
- 1119779-2024-00577
- Event Type
- Malfunction
- Date Received
- August 6, 2024
- Date of Event
- July 3, 2024
- Report Date
- September 17, 2025
- Manufacturer
- BECTON DICKINSON & CO. (SPARKS)
- Product Code
- PPM
- UDI-DI
- 00382902123545
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 4060093. D4. MEDICAL DEVICE EXPIRATION DATE: 20-AUG-2024. H4. DEVICE MANUFACTURE DATE: 29-FEB-2024. QUANTITY: UNSPECIFIED. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
INVESTIGATION SUMMARY: MATERIAL 212354 IS MANUFACTURED BY REHYDRATING THE MEDIA COMPONENTS WITH USP PURIFIED WATER, AND THOROUGHLY MIXING UNTIL A HOMOGENEOUS SOLUTION IS OBTAINED. THE TUBES ARE FILLED, CAPPED, TORQUED AND THEN LABELED BY MACHINE PER STANDARD OPERATING PROCEDURE (SOP). THE TUBES ARE TERMINALLY AUTOCLAVED IN AN AIR OVER PRESSURE (AOP) AUTOCLAVE, PER MANUFACTURING INSTRUCTIONS, USING A VALIDATED CYCLE. POST AUTOCLAVING, TUBES ARE PACKAGED INTO FINAL SHIPPING CONFIGURATIONS. THE BATCH HISTORY RECORD FOR BATCHES 3207657 OR 4060093 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. FORMULATION, FILLING AND AUTOCLAVING PROCESSES WERE WITHIN SPECIFICATIONS. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON BATCH 3207657 OR 4060093. AT THE TIME OF THE COMPLAINT INVESTIGATION, BATCHES 3207657 (EXP 2024-01-23) AND 4060093 (EXP 2024-08-20) WERE BOTH EXPIRED AND RETENTION SAMPLES WERE UNABLE TO BE TESTED AS PART OF THE INVESTIGATION. NO RETURNS OR PHOTOS WERE PROVIDED FOR INVESTIGATION. THE COMPLAINT HISTORY WAS REVIEWED FOR MATERIAL 212354 AND THERE ARE NO TRENDS IN ANY BATCH OVER THE LAST 12 MONTHS. BD WILL CONTINUE TO TREND FOR THIS ISSUE. THIS COMPLAINT CANNOT BE CONFIRMED.
THE FOLLOWING FIELDS HAVE BEEN UPDATED: B5. IT WAS REPORTED WHILE USING BD BBL¿ VITAMIN K1 - HEMIN SOLUTION IN A RESEARCH STUDY ON HEALTHY PATIENT VOLUNTEERS, AN UNKNOWN NUMBER OF SAMPLES EXHIBITED PERFORMANCE ISSUES WITH A DECREASE IN THE BACTERIA RICHNESS. THERE WAS NO REPORT OF PATIENT IMPACT. THIS SUPPLEMENTAL MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING APRIL 2023¿2025, UNDER CAPA 11910483.
THE FOLLOWING UPDATES HAVE BEEN MADE: THIS MDR PERTAINS ONLY TO LOT NUMBER 3207657.
IT WAS REPORTED WHILE USING BD BBL¿ VITAMIN K1 - HEMIN SOLUTION IN A RESEARCH STUDY ON HEALTHY PATIENT VOLUNTEERS, AN UNSPECIFIED NUMBER OF SAMPLES EXHIBITED PERFORMANCE ISSUES WITH A DECREASE IN THE BACTERIA RICHNESS. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
IT WAS REPORTED WHILE USING BD BBL¿ VITAMIN K1 - HEMIN SOLUTION IN A RESEARCH STUDY ON HEALTHY PATIENT VOLUNTEERS, AN UNSPECIFIED NUMBER OF SAMPLES EXHIBITED PERFORMANCE ISSUES WITH A DECREASE IN THE BACTERIA RICHNESS. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
IT WAS REPORTED WHILE USING BD BBL¿ VITAMIN K1 - HEMIN SOLUTION IN A RESEARCH STUDY ON HEALTHY PATIENT VOLUNTEERS, AN UNKNOWN NUMBER OF SAMPLES EXHIBITED PERFORMANCE ISSUES WITH A DECREASE IN THE BACTERIA RICHNESS. THERE WAS NO REPORT OF PATIENT IMPACT.
IT WAS REPORTED WHILE USING BD BBL¿ VITAMIN K1 - HEMIN SOLUTION IN A RESEARCH STUDY ON HEALTHY PATIENT VOLUNTEERS, AN UNSPECIFIED NUMBER OF SAMPLES EXHIBITED PERFORMANCE ISSUES WITH A DECREASE IN THE BACTERIA RICHNESS. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1561182 | BD BBL¿ VITAMIN K1 - HEMIN SOLUTION | GENERAL PURPOSE REAGENT | PPM | BECTON DICKINSON & CO. (SPARKS) | 3207657 | 00382902123545 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |