BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC)
Report
- Report Number
- 3008352382-2023-00109
- Event Type
- Malfunction
- Date Received
- June 26, 2023
- Date of Event
- June 7, 2023
- Report Date
- September 23, 2023
- Manufacturer
- BECTON DICKINSON CARIBE LTD.
- Product Code
- MDB
- UDI-DI
- 00382904420222
- PMA / PMN Number
- K141810
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. H4. DEVICE MANUFACTURE DATE: UNKNOWN.
H.6. INVESTIGATION SUMMARY: CUSTOMER REPORTED ISSUED RELATED TO THE EIFU. NEITHER PHOTOS NOR RETURNED GOOD SAMPLES WERE RECEIVED. VERIFICATION TO THE HTTPS://EIFU.BD.COM WAS VERIFIED FOR CATALOGS 442021 AND 442022, AND THE CORRECT IFU'S WERE DOWNLOADED. A COMPLAINT HISTORY REVIEW WAS CONDUCTED AND ONLY THE CURRENT COMPLAINT WAS FOUND RELATING TO THE INCIDENT THE ¿AS REPORTED¿ DEFECT CODE. THE BATCH HISTORY RECORD WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN NONETHELESS BATCH HISTORY RECORDS ARE ALWAYS REVIEWED PRIOR TO PRODUCT RELEASE. INVESTIGATION CANNOT BE CONDUCTED TO THE RETENTION SAMPLES SINCE THE LOT NUMBER IS UNKNOWN. A CROSS FUNCTIONAL TEAM CONTINUALLY MONITORS ALL PRODUCT COMPLAINTS FOR TRENDS AND DETERMINES IF ANY ADDITIONAL ACTIONS ARE NECESSARY BEYOND THE CURRENT INVESTIGATION PROCESS. THE BD LABELING TEAM HAS REVIEWED THE ISSUE AND CONFIRMED AN INCORRECT DOCUMENT WAS DISPLAYED ON THE EIFU SITE. A TECHNICAL ISSUE WITH THE DOCUMENT LINK WAS IDENTIFIED AS PART OF THIS COMPLAINT AND A CORRECTIVE AND PREVENTATIVE ACTION WAS INITIATED IN ORDER TO ENSURE THE ISSUE IS BEING ADDRESSED AND CORRECTED MOVING FORWARD. BD APOLOGIZES FOR ANY INCONVENIENCE THIS HAS CAUSED. THE BD EIFU SITE ALSO DIRECTS USERS TO CUSTOMER SERVICE IN THE EVENT AN ERROR IS IN PLACE WITH THE SITE. A COPY OF THE IFU CAN BE REQUESTED BY CONTACTING BD TECHNICAL SERVICES.
IT WAS REPORTED THAT THE INSTRUCTIONS FOR USE PROVIDED WITH BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC) WERE FOR THE INCORRECT PRODUCT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PRODUCT INSERT FOR THE BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS I RECEIVED AT MY LABORATORY WITH LOT WE RECEIVED: 8090999(08) 2019-09. THE DOCUMENTATION I HAVE FOR THE PREVIOUS LOT WE RECEIVED FROM BD IS BELOW:8089974(08) 2019-09. COULD YOU PLEASE LET ME KNOW IF/WHAT THE CHANGES WERE BETWEEN THESE TWO DOCUMENTS? STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: ADVISED THAT DOC# 8090999(08) 2019-09 IS FOR CATALOG 442022 BD BACTEC¿ PLUS ANAEROBIC/F MEDIUM, CASE OF 50 PLASTIC VIALS AND DOC # 8089974(08) 2019-09 IS FOR CATALOG 442021 BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS.
IT WAS REPORTED THAT THE INSTRUCTIONS FOR USE PROVIDED WITH BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC) WERE FOR THE INCORRECT PRODUCT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PRODUCT INSERT FOR THE BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS I RECEIVED AT MY LABORATORY WITH LOT WE RECEIVED:8090999(08) 2019-09. THE DOCUMENTATION I HAVE FOR THE PREVIOUS LOT WE RECEIVED FROM BD IS BELOW:8089974(08) 2019-09. COULD YOU PLEASE LET ME KNOW IF/WHAT THE CHANGES WERE BETWEEN THESE TWO DOCUMENTS?
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1477810 | BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC) | SYSTEM, BLOOD CULTURING | MDB | BECTON DICKINSON CARIBE LTD. | 442022 | UNKNOWN | 00382904420222 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |