BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC)
Report
- Report Number
- 1119779-2022-01207
- Event Type
- Malfunction
- Date Received
- September 19, 2022
- Date of Event
- August 30, 2022
- Report Date
- December 15, 2022
- Manufacturer
- BECTON DICKINSON CARIBE LTD.
- Product Code
- MDB
- UDI-DI
- 00382904420222
- PMA / PMN Number
- K123903
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
D.4. MEDICAL DEVICE LOT #: 2040079. D.4. MEDICAL DEVICE EXPIRATION DATE: 12/2022. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. D.4. MEDICAL DEVICE LOT #: 2069872. D.4. MEDICAL DEVICE EXPIRATION DATE: 12/2022. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
H6: INVESTIGATION SUMMARY: CATALOG 442021. BATCH NO. 2040079 & 2069872. NEITHER PHOTOS NOR RETURNED GOOD SAMPLES WERE RECEIVED. RETENTION SAMPLES WERE VISUALLY INSPECTED, TESTED FOR VIABLE CONTAMINATION BY SUB-CULTURING ON TSA, CHOCOLATE, SABOURAUD AND SCHAEDLER AGARS PLATES, VOLTAGE OUTPUT AND GRAM STAIN. ALL RESULTS WERE SATISFACTORY. BATCH HISTORY RECORD REVIEW DID NOT IDENTIFY ANY EVIDENCE FOR WHICH THE CUSTOMER SUBMITTED THE COMPLAINT. A COMPLAINT HISTORY REVIEW WAS CONDUCTED AND ONLY THE CURRENT COMPLAINT WAS FOUND RELATING TO THE INCIDENT LOT NUMBER AND THE ¿AS REPORTED¿ DEFECT CODE. COMPLAINT IS UNCONFIRMED BASED ON RETENTION SAMPLES AND BATCH HISTORY RECORD REVIEW RESULTS. PRODUCT INSERT WARNINGS AND PRECAUTIONS SECTIONS STATES THAT PRIOR TO USE, EACH VIAL SHOULD BE EXAMINED FOR EVIDENCE OF CONTAMINATION SUCH AS CLOUDINESS, BULGING OR DEPRESSES SEPTUM, OR LEAKAGE. VIALS SHOWING EVIDENCE OF CONTAMINATION SHOULD NOT BE USED. ALSO PRIOR TO USE, THE USER SHOULD EXAMINE THE VIAL FOR EVIDENCE OF DAMAGE OR DETERIORATION. VIALS DISPLAYING TURBIDITY, CONTAMINATION, OR DISCOLORATION (DARKENING) SHOULD NOT BE USED. A CROSS FUNCTIONAL TEAM CONTINUALLY MONITORS ALL PRODUCT COMPLAINTS FOR TRENDS AND DETERMINES IF ANY ADDITIONAL ACTIONS ARE NECESSARY BEYOND THE CURRENT INVESTIGATIONAL PROCESS.
MEDICAL DEVICE LOT #: 2040079, MEDICAL DEVICE EXPIRATION DATE: 12/2022, DEVICE MANUFACTURE DATE: UNKNOWN. MEDICAL DEVICE LOT #: 2069872, MEDICAL DEVICE EXPIRATION DATE: 12/2022, DEVICE MANUFACTURE DATE: UNKNOWN. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS CONTAMINATION ON BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC). THERE WAS TWO OCCURRENCES IN THIS EVENT WITH NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: "CUSTOMER REPORTED A POSSIBLE VIAL CONTAMINATION IN THE LOT#2040079 & 2069872 EXP 12/2022.".
IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS CONTAMINATION ON BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC). THERE WAS TWO OCCURRENCES IN THIS EVENT WITH NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: "CUSTOMER REPORTED A POSSIBLE VIAL CONTAMINATION IN THE LOT #2040079 & 2069872 EXP 12/2022."
IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS CONTAMINATION ON BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC). THERE WAS TWO OCCURRENCES IN THIS EVENT WITH NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: "CUSTOMER REPORTED A POSSIBLE VIAL CONTAMINATION IN THE LOT#2040079 & 2069872 EXP 12/2022."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 568409 | BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) | SYSTEM, BLOOD CULTURING | MDB | BECTON DICKINSON CARIBE LTD. | 442022 | SEE H.10 | 00382904420222 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |