BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC)
Report
- Report Number
- 2647876-2023-00041
- Event Type
- Malfunction
- Date Received
- June 19, 2023
- Date of Event
- May 8, 2023
- Report Date
- September 23, 2023
- Manufacturer
- BD CARIBE, LTD
- Product Code
- MDB
- UDI-DI
- 00382904420222
- PMA / PMN Number
- K141810
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.6. INVESTIGATION SUMMARY: CATALOG: 442022. BATCH NO.: 2291859 & 2284986. 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: 442022. BATCH NO.: UNKNOWN. CUSTOMER REPORTED A POSITIVE ID RESULT FOR BACTEC MEDIA, WHILE USING BIOFIRE FILMARRAY® BLOOD CULTURE IDENTIFICATION PANELS. NEITHER PHOTOS NOR RETURNED GOOD SAMPLES WERE RECEIVED. INVESTIGATION CANNOT BE CONDUCTED TO THE RETENTION SAMPLES SINCE THE LOT 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. COMPLAINT IS UNCONFIRMED. H3 OTHER TEXT : SEE H.10.
D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. DEVICE MANUFACTURE DATE: UNKNOWN.
IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) THERE WERE MOLECULAR FALSE POSITIVE RESULTS. THERE WERE SIX OCCURRENCES. NO ERRONEOUS RESULTS REPORTED TO CLINICIANS. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PT # 5, 15-CB-23-053255: LOT #: UNKNOWN SEQUENCE #: 449376627846. INSTRUMENT S/N: (B)(6). NO ERRONEOUS RESULTS REPORTED BCID RESULT: ENTEROCOCCUS FAECALIS, ENTEROBACTERALES, PROTEUS SPP., KLEB PNEUMONIAE, C. TROPICALIS BCID2, LOT #: 2S2V23. GRAM STAIN: GPR, GPC IN PAIRS AND CHAINS CULTURE GREW KLEB PNEUMONIAE, PROTEUS MIRABILIS, ENTEROCOCCUS FAECALIS, ENTEROCOCCUS AVIUM".
REPORT 5 OF 6. IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) THERE WERE MOLECULAR FALSE POSITIVE RESULTS. THERE WERE SIX OCCURRENCES. NO ERRONEOUS RESULTS REPORTED TO CLINICIANS. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PT # 5, 15-CB-23-053255: LOT #: UNKNOWN SEQUENCE #: 449376627846 INSTRUMENT S/N: (B)(6) NO ERRONEOUS RESULTS REPORTED BCID RESULT: ENTEROCOCCUS FAECALIS, ENTEROBACTERALES, PROTEUS SPP., KLEB PNEUMONIAE, C. TROPICALIS BCID2, LOT #: 2S2V23 GRAM STAIN: GPR, GPC IN PAIRS AND CHAINS CULTURE GREW KLEB PNEUMONIAE, PROTEUS MIRABILIS, ENTEROCOCCUS FAECALIS, ENTEROCOCCUS AVIUM"
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 777330 | BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC) | SYSTEM, BLOOD CULTURING | MDB | BD CARIBE, LTD | 442022 | UNKNOWN | 00382904420222 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |