BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)
Report
- Report Number
- 2647876-2022-00223
- Event Type
- Malfunction
- Date Received
- October 21, 2022
- Date of Event
- October 6, 2022
- Report Date
- November 16, 2022
- Manufacturer
- BECTON DICKINSON CARIBE LTD.
- Product Code
- MDB
- UDI-DI
- 00382904420239
- PMA / PMN Number
- K113558
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
D.4. LOT # AND EXPIRATION DATE HAVE BEEN UPDATED FROM UNKNOWN TO --- LOT NUMBER: 1153264, EXPIRATION DATE: 03/31/2022.
INVESTIGATION SUMMARY: CUSTOMER REPORTED A FALSE NEGATIVE RESULT. NEITHER PHOTOS NOR RETURNED GOOD SAMPLES WERE RECEIVED. UPON FURTHER EVALUATION IT WAS NOTICED THAT COMPLAINT RECEIVED WAS FROM A PRODUCT ALREADY EXPIRED. INVESTIGATION CANNOT BE CONDUCTED TO THE RETENTION SAMPLES SINCE THE PRODUCT IS ALREADY EXPIRED. 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. THE BATCH HISTORY RECORD WAS NOT REVIEWED AS THE LOT IS EXPIRED, NONETHELESS BATCH HISTORY RECORDS ARE ALWAYS REVIEWED PRIOR TO PRODUCT RELEASE. 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. THE SPECIMEN MUST BE COLLECTED USING STERILE TECHNIQUES TO REDUCE THE CHANCE OF CONTAMINATION. DO NOT USE CULTURE VIALS PAST THEIR EXPIRATION DATE. COMPLAINT IS UNCONFIRMED. NO CORRECTIVE ACTIONS WERE REQUIRED. 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 EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 THAT BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) HAD A FALSE NEGATIVE BLOOD CULTURE AFTER A 5 DAY INCUBATION. A WEEK LATER ANOTHER BLOOD CULTURE WAS SENT FOR ANALYSIS AND GAVE A POSITIVE RESULT. THE NEGATIVE BOTTLE WAS STILL AVAILABLE AND SUB CULTURED, WHICH GAVE A POSITIVE RESULT. BOTH NEGATIVE AND POSITIVE BLOOD CULTURE BOTTLES CONTAINED FRANCISELLA TULARENSIS. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FALSE NEGATIVE BLOOD CULTURE. BLOOD CULTURE WAS PERFORMED AND GAVE A NEGATIVE RESULT AFTER 5 DAY INCUBATION. ONE WEEK LATER, ANOTHER BLOOD CULTURE WAS SENT FOR ANALYSIS AND GAVE A POSITIVE RESULT. THE NEGATIVE BOTTLE WAS STILL AVAILABLE AND SUBCULTURED. THIS SUBCULTURE FROM THE NEGATIVE BOTTLE WAS POSITIVE. I NEED TO SPECIFY: THE NEGATIVE AND POSITIVE BLOOD CULTURE BOTTLES CONTAINED FRANCISELLA TULARENSIS. THE LOT NUMBER IS UNFORTUNATELY NOT AVAILABLE ANYMORE. THE BOTTLES HAVE BEEN DISCARDED. HOWEVER, I CAN PROVIDE THE BARCODE NUMBER OF THE BOTTLE, AS THIS WAS AVAILABLE IN EPICENTRE: 449283366231 THE SERIAL NUMBER OF THE INSTRUMENT IS (B)(6).
IT WAS REPORTED THAT BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) HAD A FALSE NEGATIVE BLOOD CULTURE AFTER A 5 DAY INCUBATION. A WEEK LATER ANOTHER BLOOD CULTURE WAS SENT FOR ANALYSIS AND GAVE A POSITIVE RESULT. THE NEGATIVE BOTTLE WAS STILL AVAILABLE AND SUB CULTURED, WHICH GAVE A POSITIVE RESULT. BOTH NEGATIVE AND POSITIVE BLOOD CULTURE BOTTLES CONTAINED FRANCISELLA TULARENSIS. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FALSE NEGATIVE BLOOD CULTURE. BLOOD CULTURE WAS PERFORMED AND GAVE A NEGATIVE RESULT AFTER 5 DAY INCUBATION. ONE WEEK LATER, ANOTHER BLOOD CULTURE WAS SENT FOR ANALYSIS AND GAVE A POSITIVE RESULT. THE NEGATIVE BOTTLE WAS STILL AVAILABLE AND SUBCULTURED. THIS SUBCULTURE FROM THE NEGATIVE BOTTLE WAS POSITIVE. I NEED TO SPECIFY: THE NEGATIVE AND POSITIVE BLOOD CULTURE BOTTLES CONTAINED FRANCISELLA TULARENSIS. THE LOT NUMBER IS UNFORTUNATELY NOT AVAILABLE ANYMORE. THE BOTTLES HAVE BEEN DISCARDED. HOWEVER, I CAN PROVIDE THE BARCODE NUMBER OF THE BOTTLE, AS THIS WAS AVAILABLE IN EPICENTRE: (B)(6). THE SERIAL NUMBER OF THE INSTRUMENT IS (B)(6).
IT WAS REPORTED THAT BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) HAD A FALSE NEGATIVE BLOOD CULTURE AFTER A 5 DAY INCUBATION. A WEEK LATER ANOTHER BLOOD CULTURE WAS SENT FOR ANALYSIS AND GAVE A POSITIVE RESULT. THE NEGATIVE BOTTLE WAS STILL AVAILABLE AND SUB CULTURED, WHICH GAVE A POSITIVE RESULT. BOTH NEGATIVE AND POSITIVE BLOOD CULTURE BOTTLES CONTAINED FRANCISELLA TULARENSIS. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FALSE NEGATIVE BLOOD CULTURE. BLOOD CULTURE WAS PERFORMED AND GAVE A NEGATIVE RESULT AFTER 5 DAY INCUBATION. ONE WEEK LATER, ANOTHER BLOOD CULTURE WAS SENT FOR ANALYSIS AND GAVE A POSITIVE RESULT. THE NEGATIVE BOTTLE WAS STILL AVAILABLE AND SUBCULTURED. THIS SUBCULTURE FROM THE NEGATIVE BOTTLE WAS POSITIVE. I NEED TO SPECIFY: THE NEGATIVE AND POSITIVE BLOOD CULTURE BOTTLES CONTAINED FRANCISELLA TULARENSIS. THE LOT NUMBER IS UNFORTUNATELY NOT AVAILABLE ANYMORE. THE BOTTLES HAVE BEEN DISCARDED. HOWEVER, I CAN PROVIDE THE BARCODE NUMBER OF THE BOTTLE, AS THIS WAS AVAILABLE IN EPICENTRE: 449283366231 THE SERIAL NUMBER OF THE INSTRUMENT IS (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1648180 | BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) | SYSTEM, BLOOD CULTURING | MDB | BECTON DICKINSON CARIBE LTD. | 442023 | 1153264 | 00382904420239 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |