BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC)
Report
- Report Number
- 2647876-2022-00130
- Event Type
- Malfunction
- Date Received
- May 6, 2022
- Date of Event
- April 6, 2022
- Report Date
- May 23, 2022
- Manufacturer
- BECTON DICKINSON CARIBE LTD.
- Product Code
- MDB
- UDI-DI
- 00382904420222
- PMA / PMN Number
- K141810
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1175560, MEDICAL DEVICE EXPIRATION DATE: 16-JUNE-2021, DEVICE MANUFACTURE DATE: 31-MAR-2022. MEDICAL DEVICE LOT #: 1167259, MEDICAL DEVICE EXPIRATION DATE: 24-JUNE- 2021, DEVICE MANUFACTURE DATE: 30-APR-2022/ A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
H.6. INVESTIGATION: CUSTOMER REPORTED A POSITIVE ID RESULT FOR BACTEC MEDIA, WHILE USING BIOFIRE FILMARRAY® BLOOD CULTURE IDENTIFICATION BDIC/BCID2 PANELS. 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 COULD NOT BE REVIEWED AS THE LOT IS EXPIRED, NONETHELESS BATCH HISTORY RECORDS ARE ALWAYS REVIEWED PRIOR TO PRODUCT RELEASE. NO INVESTIGATION CAN BE CONDUCTED TO THE RETENTION SAMPLES SINCE THE PRODUCT IS ALREADY EXPIRED. COMPLAINT IS UNCONFIRMED. AS PER PRODUCT INSERT A GRAM-STAINED SMEAR FROM CULTURE MEDIUM MAY CONTAIN SMALL NUMBERS OF NONVIABLE ORGANISMS DERIVED FROM MEDIA CONSTITUENTS, STAINING REAGENTS, IMMERSION OIL, GLASS SLIDES, AND SPECIMENS USED FOR INOCULATION. DUE TO THE NATURE OF BIOLOGICAL MATERIALS IN MEDIA PRODUCTS AND INHERENT ORGANISM VARIABILITY, THE USER SHOULD BE COGNIZANT OF POTENTIAL VARIABLE RESULTS IN THE RECOVERY OF CERTAIN MICROORGANISMS. MOLECULAR TESTS PERFORMED ON POSITIVE BLOOD CULTURES WILL DETECT BOTH VIABLE AND NON-VIABLE ORGANISMS COMMONLY FOUND IN CULTURE MEDIA. THEREFORE, MOLECULAR TEST RESULTS SHOULD BE EVALUATED IN CONJUNCTION WITH GRAM STAIN RESULTS IN ACCORDANCE WITH STANDARD-OF-CARE PRACTICES AS WELL AS MANUFACTURER¿S INSTRUCTIONS FOR USE. 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.
IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC) 15 FALSE POSITIVE OCCURRED. 13 OF THESE FALSE RESULTS WERE NOT REPORTED TO THE CLINICIAN OR THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN OUR HOSPITAL ROUTINE, BLOOD SAMPLES FOR CULTURE ARE COLLECTED IN BOTTLES 442023/BD BACTEC PLUS AEROBIC MEDIUM OR 442022/BD BACTEC PLUS ANAEROBIC MEDIUM AND INCUBATED IN THE BACTEC 9240 EQUIPMENT. BLOOD CULTURES DETECTED AS POSITIVE BY THE SYSTEM ARE IMMEDIATELY SMEARED AND BACTERIOSCOPY PERFORMED USING THE GRAM METHOD. THOSE IN WHICH THE PRESENCE OF GRAM-POSITIVE COCCI (GGC) IS EVIDENCED WITHIN A PERIOD OF LESS THAN 24 HOURS FROM THE MOMENT OF COLLECTION OR THAT PRESENT GRAM-NEGATIVE RODS (GNB) ARE IMMEDIATELY REFERRED TO THE BCID2 PANEL. IN OUR CURRENT ROUTINE, THE BCID2 PANEL KIT WAS RECEIVED IN NOVEMBER 2021 AND READILY AVAILABLE FOR USE. ON (B)(6) 2021, WE HAD THE FIRST FALSE POSITIVE CASE FOR ACINETOBACTER CALCOACETICUS-BAUMANNII COMPLEX AND SINCE THEN WE HAVE OBSERVED AN INCREASING NUMBER OF RESULTS THAT DETECTED THE MICROORGANISM, BUT THEY WERE NOT RECOVERED IN TRADITIONAL CULTURES. WE OBSERVED A TOTAL OF 15 FALSE POSITIVE RESULTS FOR ACINETOBACTER CALCOACETICUS-BAUMANNII COMPLEX, ALL WITH MORE THAN ONE MICROORGANISM DETECTED. THERE WERE 13 GRAM NEGATIVE BACTERIA RESULTS, ONE WITH GRAM POSITIVE AND ONE WITH AN ASSOCIATION BETWEEN THE TWO. AMONG THE FALSE POSITIVES, WE FOLLOWED TWO IMPORTANT CASES (DETAILS OF CASES WITHIN (B)(4)) THAT OCCURRED IN PARALLEL. AN OCTOBER 2021 U.S FOOD AND DRUG ADMINISTRATION (FDA) ADVISORY WAS FOUND FOR BLOOD CULTURE IDENTIFICATION 2 (BCID2) RECALL NUMBER Z-0312-2022, RECALL EVENT ID (B)(4). ACCORDING TO THE ADVISORY, THE RECALL WAS MADE DUE TO FALSE POSITIVE INCREASE FOR RESULTS FOR ACINETOBACTER CALCOACETICUS-BAUMANNII COMPLEX, RELATED TO NON-VIABLE CONTAMINATION OF CULTURE VIALS. THE BOTTLES USED IN OUR LABORATORY ROUTINE HAVE THE SAME REFERENCES HIGHLIGHTED IN THE AMERICAN REGULATORY DOCUMENT. VERIFIED WITH RCC A TOTAL OF 15 FALSE POSITIVES OVER (B)(4) (2 MATERIAL #'S AND 4 LOT #'S) - THIS PR IS FOR (B)(4). THE FOLLOWING MATERIAL AND LOT #'S WERE REPORTED TO BE EFFECTED: MATERIAL # 442022 ¿ LOT #¿S 1167259 / 1175560. MATERIAL # 442023 ¿ LOT #¿S 1167767 / 1181333. TOTAL 15 FALSE POSITIVES SPLIT AMONG THESE MATERIAL #¿S AND LOT #¿S. SEPARATE MDR SUBMITTED FOR EACH MATERIAL #.
IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC) 15 FALSE POSITIVE OCCURRED. 13 OF THESE FALSE RESULTS WERE NOT REPORTED TO THE CLINICIAN OR THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN OUR HOSPITAL ROUTINE, BLOOD SAMPLES FOR CULTURE ARE COLLECTED IN BOTTLES 442023/BD BACTEC PLUS AEROBIC MEDIUM OR 442022/BD BACTEC PLUS ANAEROBIC MEDIUM AND INCUBATED IN THE BACTEC 9240 EQUIPMENT. BLOOD CULTURES DETECTED AS POSITIVE BY THE SYSTEM ARE IMMEDIATELY SMEARED AND BACTERIOSCOPY PERFORMED USING THE GRAM METHOD. THOSE IN WHICH THE PRESENCE OF GRAM-POSITIVE COCCI (GGC) IS EVIDENCED WITHIN A PERIOD OF LESS THAN 24 HOURS FROM THE MOMENT OF COLLECTION OR THAT PRESENT GRAM-NEGATIVE RODS (GNB) ARE IMMEDIATELY REFERRED TO THE BCID2 PANEL. IN OUR CURRENT ROUTINE, THE BCID2 PANEL KIT WAS RECEIVED IN NOVEMBER 2021 AND READILY AVAILABLE FOR USE. ON NOVEMBER 5, 2021, WE HAD THE FIRST FALSE POSITIVE CASE FOR ACINETOBACTER CALCOACETICUS-BAUMANNII COMPLEX AND SINCE THEN WE HAVE OBSERVED AN INCREASING NUMBER OF RESULTS THAT DETECTED THE MICROORGANISM, BUT THEY WERE NOT RECOVERED IN TRADITIONAL CULTURES. WE OBSERVED A TOTAL OF 15 FALSE POSITIVE RESULTS FOR ACINETOBACTER CALCOACETICUS-BAUMANNII COMPLEX, ALL WITH MORE THAN ONE MICROORGANISM DETECTED. THERE WERE 13 GRAM NEGATIVE BACTERIA RESULTS, ONE WITH GRAM POSITIVE AND ONE WITH AN ASSOCIATION BETWEEN THE TWO. AMONG THE FALSE POSITIVES, WE FOLLOWED TWO IMPORTANT CASES (DETAILS OF CASES WITHIN RECS 4929278 AND 4929631) THAT OCCURRED IN PARALLEL. AN OCTOBER 2021 U.S FOOD AND DRUG ADMINISTRATION (FDA) ADVISORY WAS FOUND FOR BLOOD CULTURE IDENTIFICATION 2 (BCID2) RECALL NUMBER Z-0312-2022, RECALL EVENT ID 88934. ACCORDING TO THE ADVISORY, THE RECALL WAS MADE DUE TO FALSE POSITIVE INCREASE FOR RESULTS FOR ACINETOBACTER CALCOACETICUS-BAUMANNII COMPLEX, RELATED TO NON-VIABLE CONTAMINATION OF CULTURE VIALS. THE BOTTLES USED IN OUR LABORATORY ROUTINE HAVE THE SAME REFERENCES HIGHLIGHTED IN THE AMERICAN REGULATORY DOCUMENT. VERIFIED WITH RCC A TOTAL OF 15 FALSE POSITIVES OVER PR'S 4929631 AND 4929278 (2 MATERIAL #'S AND 4 LOT #'S) - THIS PR IS FOR 442022. THE FOLLOWING MATERIAL AND LOT #'S WERE REPORTED TO BE EFFECTED: MATERIAL # 442022 ¿ LOT #¿S 1167259 / 1175560. MATERIAL # 442023 ¿ LOT #¿S 1167767 / 1181333. TOTAL 15 FALSE POSITIVES SPLIT AMONG THESE MATERIAL #¿S AND LOT #¿S. SEPARATE MDR SUBMITTED FOR EACH MATERIAL #.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1073707 | BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC) | SYSTEM, BLOOD CULTURING | MDB | BECTON DICKINSON CARIBE LTD. | 1167259 | 00382904420222 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |