BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)
Report
- Report Number
- 3008352382-2023-00105
- Event Type
- Malfunction
- Date Received
- June 11, 2023
- Date of Event
- April 22, 2023
- Report Date
- July 18, 2023
- Manufacturer
- BECTON DICKINSON CARIBE LTD.
- Product Code
- MDB
- UDI-DI
- 00382904420239
- PMA / PMN Number
- K113558
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.6 INVESTIGATION SUMMARY: CATALOG: 442023. BATCH NO.:3031790 & 3011327. CUSTOMER REPORTED A POSITIVE ID RESULT FOR BACTEC MEDIA, WHILE USING BIOFIRE FILMARRAY® BLOOD CULTURE IDENTIFICATION. NEITHER PHOTOS NOR RETURNED GOOD SAMPLES WERE RECEIVED. BD WAS UNABLE TO REPRODUCE THE CUSTOMER¿S EXPERIENCE WITH THE BACTEC PRODUCT BASED ON OUR INTERNAL PROCEDURES AND THE INTENDED USE OF THE PRODUCT. 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. CATALOG 442023. BATCH NO. UNKNOWN. CUSTOMER REPORTED A POSITIVE ID RESULT FOR BACTEC MEDIA, WHILE USING BIOFIRE FILMARRAY® BLOOD CULTURE IDENTIFICATION. NEITHER PHOTOS NOR RETURNED GOOD SAMPLES WERE RECEIVED. BD WAS NOT ABLE TO PERFORM AN INVESTIGATION TO THE RETENTION SAMPLES SINCE BATCH NUMBER IS UNKNOWN. A COMPLAINT HISTORY REVIEW CANNOT BE CONDUCTED RELATING TO THE INCIDENT LOT NUMBER AND THE ¿AS REPORTED¿ DEFECT CODE SINCE BATCH NUMBER IS UNKNOWN. THE BATCH HISTORY RECORD COULD NOT BE REVIEWED AS THE LOT NUMBER IS UNKNOWN NONETHELESS BATCH HISTORY RECORDS ARE ALWAYS REVIEWED PRIOR TO PRODUCT RELEASE.
A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
REPORT 5 OF 7. IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) CANDIDA TROPICALIS FALSE POSITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DIAGNOSIS OF SEPSIS, UTI. PATIENT WAS NOT HARMED, NOR WAS PATIENT AFFECTED BY FILMARRAY RESULT. RESULT REPORTED TO PHYSICIAN- E.COLI - NO GENES DETECTED. FILMARRAY WAS REPEATED DUE TO CANDIDA TROPICALIS ON BIOFIRE PRINTOUT. GRAMSTAIN- GRAM NEGATIVE RODS, SAMPLE IS AVAILABLE. SAMPLE-BLOOD CULTURE WITH COLLECTION DATE OF 4/21. BLOOD CULTURE AEROBIC BOTTLE, LOT NUMBER 3011327, EXPIRATION DATE OF 10/13/23. TESTING ON FILMARRAY LESS THAN A HOUR.
REPORT 5 OF 7; IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) CANDIDA TROPICALIS FALSE POSITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DIAGNOSIS OF SEPSIS, UTI PATIENT WAS NOT HARMED, NOR WAS PATIENT AFFECTED BY FILMARRAY RESULT REPORTED TO PHYSICIAN- E.COLI - NO GENES DETECTED FILMARRAY WAS REPEATED DUE TO CANDIDA TROPICALIS ON BIOFIRE PRINTOUT GRAMSTAIN- GRAM NEGATIVE RODS, SAMPLE IS AVAILABLE SAMPLE-BLOOD CULTURE WITH COLLECTION DATE OF 4/21 BLOOD CULTURE AEROBIC BOTTLE, LOT NUMBER 3011327, EXPIRATION DATE OF 10/13/23. TESTING ON FILMARRAY LESS THAN A HOUR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 435291 | BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) | SYSTEM, BLOOD CULTURING | MDB | BECTON DICKINSON CARIBE LTD. | 442023 | UNKNOWN | 00382904420239 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Male |