BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC)
Report
- Report Number
- 2647876-2023-00148
- Event Type
- Malfunction
- Date Received
- September 15, 2023
- Date of Event
- August 17, 2023
- Report Date
- August 14, 2025
- Manufacturer
- BECTON DICKINSON CARIBE LTD.
- Product Code
- MDB
- UDI-DI
- 00382904420215
- PMA / PMN Number
- K123903
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
CATALOG: 442021. BATCH NO.: 3095986 AND 3117111. CUSTOMER REPORTED A MOLECULAR FALSE POSITIVE RESULT. 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. 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. CATALOG: 442021. BATCH NO.: 3130610 AND 3102666. CUSTOMER REPORTED A MOLECULAR FALSE POSITIVE RESULT. 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 BATCHES HAS BEEN PREVIOUSLY INVESTIGATED FOR THE REPORTED DEFECT. COMPLAINT IS UNCONFIRMED BASED ON RETENTION SAMPLES AND BATCHES HISTORY RECORD REVIEW RESULTS. 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.
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION. B1: ADVERSE TYPE: ADVERSE EVENT AND PRODUCT PROBLEM. B2: OTHER DETAILS: UNKNOWN LOT NUMBER/TYPE OF BOTTLE WAS TREATED AS FUNGAL INFECTION. B3: DATE OF EVENT: 17-AUG-2023. B5: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC), THERE WERE MOLECULAR FALSE POSITIVES OF 8 BOTTLES ACROSS 4 LOT NUMBERS. A TOTAL OF TWO REPORTS WERE FILED ACROSS TWO PRODUCT NUMBERS. THE INITIAL REPORTER INDICATED THAT ACROSS THESE TWO PRODUCT NUMBERS, ONE LOT NUMBER OR TYPE OF BOTTLE RECEIVED TREATMENT FOR FUNGAL INFECTION, HOWEVER, THEY ARE UNSURE WHICH ONE. NO ADDITIONAL IMPACT IS AVAILABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BACTEC 442021 MOLECULAR FALSE POSITIVE. THEY MATCH THE BCID ACCEPT THE CTROPICALIS. WAS THE BIOFIRE RESULT DUAL POSITIVE (I.E. TWO ORGANISMS DETECTED)? C.TROP , STAP.AUREUS, STREP PYOGENES, KLEB.PNEUMONIAE, STAPH,EPI, ENTEROBACTER CLOACAE. CUSTOMER UNSURE WHICH LOT NUMBER/ TYPE OF BOTTLE GOT TREATED AS FUNGAL INFECTION." H1: TYPE OF REPORTABLE EVENTS: SERIOUS INJURY.
THERE WERE FOUR LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT#: 3130610 D4. MEDICAL DEVICE EXPIRATION DATE: 15-02-2024 H4. DEVICE MANUFACTURE DATE: 10-05-2023 D4. MEDICAL DEVICE LOT#: 3095986 D4. MEDICAL DEVICE EXPIRATION DATE: 11-01-2024 H4. DEVICE MANUFACTURE DATE: 05-04-2023 D4. MEDICAL DEVICE LOT#: 3102666 D4. MEDICAL DEVICE EXPIRATION DATE: 19-01-2024 H4. DEVICE MANUFACTURE DATE: 12-04-2023 H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING UPDATES HAVE BEEN MADE: THIS MDR PERTAINS ONLY TO LOT NUMBER 3117111. B5. IT WAS REPORTED WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC), THERE WAS A MOLECULAR FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT. THIS RECORD IS BEING REOPENED TO ADDRESS THE CORRECTIONS REQUIRED FOR CAPA PR 11910483.
IT WAS REPORTED THAT WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC), THERE WERE MOLECULAR FALSE POSITIVES OF 8 BOTTLES ACROSS 4 LOT NUMBERS. A TOTAL OF TWO REPORTS WERE FILED ACROSS TWO PRODUCT NUMBERS. THE INITIAL REPORTER INDICATED THAT ACROSS THESE TWO PRODUCT NUMBERS, ONE LOT NUMBER OR TYPE OF BOTTLE RECEIVED TREATMENT FOR FUNGAL INFECTION, HOWEVER, THEY ARE UNSURE WHICH ONE. NO ADDITIONAL IMPACT IS AVAILABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BACTEC 442021 MOLECULAR FALSE POSITIVE. THEY MATCH THE BCID ACCEPT THE CTROPICALIS. WAS THE BIOFIRE RESULT DUAL POSITIVE (I.E. TWO ORGANISMS DETECTED)? C.TROP, STAP.AUREUS, STREP PYOGENES, KLEB.PNEUMONIAE, STAPH, EPI, ENTEROBACTER CLOACAE. CUSTOMER UNSURE WHICH LOT NUMBER/ TYPE OF BOTTLE GOT TREATED AS FUNGAL INFECTION."
IT WAS REPORTED THAT WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC), THERE WERE MOLECULAR FALSE POSITIVES OF 8 BOTTLES ACROSS 4 LOT NUMBERS. A TOTAL OF TWO REPORTS WERE FILED ACROSS TWO PRODUCT NUMBERS. THE INITIAL REPORTER INDICATED THAT ACROSS THESE TWO PRODUCT NUMBERS, ONE LOT NUMBER OR TYPE OF BOTTLE RECEIVED TREATMENT FOR FUNGAL INFECTION, HOWEVER, THEY ARE UNSURE WHICH ONE. NO ADDITIONAL IMPACT IS AVAILABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BACTEC 442021 MOLECULAR FALSE POSITIVE. THEY MATCH THE BCID ACCEPT THE CTROPICALIS. WAS THE BIOFIRE RESULT DUAL POSITIVE (I.E. TWO ORGANISMS DETECTED)? C.TROP , STAP.AUREUS, STREP PYOGENES, KLEB. PNEUMONIAE, STAPH, EPI, ENTEROBACTER CLOACAE. CUSTOMER UNSURE WHICH LOT NUMBER/ TYPE OF BOTTLE GOT TREATED AS FUNGAL INFECTION."
IT WAS REPORTED THAT WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC), THERE WAS MOLECULAR FALSE POSITIVES OF 6 BOTTLES. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BACTEC 442021 MOLECULAR FALSE POSITIVE. THEY MATCH THE BCID ACCEPT THE CTROPICALIS. WAS THE BIOFIRE RESULT DUAL POSITIVE (I.E. TWO ORGANISMS DETECTED)? C.TROP , STAP.AUREUS, STREP PYOGENES, KLEB.PNEUMONIAE, STAPH,EPI, ENTEROBACTER CLOACAE."
IT WAS REPORTED WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC), THERE WAS A MOLECULAR FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 294427 | BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) | SYSTEM, BLOOD CULTURING | MDB | BECTON DICKINSON CARIBE LTD. | 3117111 | 00382904420215 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |