BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)
Report
- Report Number
- 2647876-2024-00116
- Event Type
- Malfunction
- Date Received
- October 9, 2024
- Date of Event
- August 26, 2024
- Report Date
- August 14, 2025
- Manufacturer
- BECTON DICKINSON CARIBE LTD.
- Product Code
- MDB
- UDI-DI
- 00382904420239
- PMA / PMN Number
- K113558
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION SUMMARY: CATALOG 442023; BATCH NO. 4129834, 4136560 & 4171480. CUSTOMER REPORTED A CONTAMINATION ISSUE WHILE USING BACTEC PRODUCT. BD WAS UNABLE TO REPRODUCE THE CUSTOMER¿S EXPERIENCE WITH BACTEC 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. PRE-INCUBATION TO THE RETENTION SAMPLES WAS ALSO PERFORMED FOR VIABLE CONTAMINATION TEST. 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 OF THE COMPLAINTS RECEIVED, ONLY ONE COMPLAINT WAS FOUND RELATING TO THE INCIDENT LOT NUMBER AND THE ¿AS REPORTED¿ DEFECT CODE. THE COMPLAINT IS UNCONFIRMED BASED ON RETENTION SAMPLES AND BATCH HISTORY RECORD REVIEW RESULTS. BD BACTEC¿ MEDIA ARE MANUFACTURED FOLLOWING GOOD MANUFACTURING PRACTICES, WHICH INCLUDE MULTIPLE IN-PROCESS QUALITY CHECKS AND AN AUTOCLAVE MOIST HEAT STERILIZATION PROCESS PREVIOUSLY VALIDATED FOLLOWING ISO 11134 STANDARD. ADDITIONALLY, ALL BD BACTEC¿ MEDIA RELEASED FOR SALE MUST PASS QUALITY CONTROL TESTING BY PROCEDURES CONVENTIONALLY UTILIZED FOR THIS TYPE OF PRODUCT, INCLUDING METHODOLOGY AND CONTROL ATCC CULTURES SPECIFIED IN THE CLSI STANDARD, QUALITY ASSURANCE FOR COMMERCIALLY PREPARED MICROBIOLOGICAL CULTURE MEDIA. CONTROLS ARE ALSO USED DURING EACH PERFORMANCE TESTING. THIS PRODUCT MET BD DIAGNOSTICS - DIAGNOSTIC SYSTEMS STRINGENT QUALITY STANDARDS AT TIME OF BATCH/LOT RELEASE. PRODUCT INSERTS STATES THAT CARE MUST BE TAKEN TO PREVENT CONTAMINATION OF THE SAMPLE DURING COLLECTION AND INOCULATION INTO THE BD BACTEC¿ VIAL. PRIOR TO USE, EACH VIAL SHOULD BE EXAMINED FOR EVIDENCE OF CONTAMINATION SUCH AS CLOUDINESS, BULGING OR DEPRESSED SEPTUM, OR LEAKAGE. DO NOT USE ANY VIAL SHOWING EVIDENCE OF CONTAMINATION. A CONTAMINATED VIAL COULD CONTAIN POSITIVE PRESSURE. IF A CONTAMINATED VIAL IS USED FOR DIRECT DRAW, GAS OR CONTAMINATED CULTURE MEDIA COULD BE REFLUXED INTO THE PATIENT¿S VEIN. VIAL CONTAMINATION MAY NOT BE READILY APPARENT. PRIOR TO USE, THE USER SHOULD EXAMINE THE VIALS FOR EVIDENCE OF DAMAGE OR DETERIORATION. VIALS THAT ARE CRACKED OR LEAKING, OR DISPLAY TURBIDITY, CONTAMINATION, OR DISCOLORATION (DARKENING) SHOULD NOT BE USED. THE SPECIMEN MUST BE COLLECTED USING STERILE TECHNIQUES TO REDUCE THE CHANCE OF CONTAMINATION. 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 INFORMATION: B5. ENTRY DESCRIPTION: IT WAS REPORTED THAT WHEN USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS BIOLOGICAL CONTAMINATION SEEN IN MULTIPLE BOTTLES SHOWING A SLOW GROWING GRAM NEGATIVE BACILLI CONSISTENT WITH BURKHOLDERIA/PARABURKHOLDERIA SPECIES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #:4129834, D4. MEDICAL DEVICE EXPIRATION DATE: 10-FEB-2025, H4. DEVICE MANUFACTURE DATE: 08-MAY-2024, D4. UNIQUE IDENTIFIER (UDI): (B)(4). D4. MEDICAL DEVICE LOT #: 4136560, D4. MEDICAL DEVICE EXPIRATION DATE: 17-FEB-2025, H4. DEVICE MANUFACTURE DATE: 15-MAY-2024, D4. UNIQUE IDENTIFIER (UDI): (B)(4). D4. MEDICAL DEVICE LOT #: 4171480, D4. MEDICAL DEVICE EXPIRATION DATE:27-MAR-2025, H4. DEVICE MANUFACTURE DATE: 19-JUN-2024, D4. UNIQUE IDENTIFIER (UDI): (B)(4).
D4. MEDICAL DEVICE LOT#: UNKNOWN. D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H4. DEVICE MANUFACTURE DATE: UNKNOWN. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G4. PMA / 510(K)#: K222591. 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 4129834. B5. IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC), THERE WAS A FALSE RESULT DUE TO CONTAMINATION. THERE WAS NO REPORT OF PATIENT IMPACT. THIS RECORD IS BEING REOPENED TO ADDRESS THE CORRECTIONS REQUIRED FOR CAPA PR (B)(4).
IT WAS REPORTED THAT WHEN USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS BIOLOGICAL CONTAMINATION SEEN IN MULTIPLE BOTTLES SHOWING A SLOW GROWING GRAM NEGATIVE BACILLI CONSISTENT WITH BURKHOLDERIA/PARABURKHOLDERIA SPECIES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
IT WAS REPORTED THAT WHEN USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS BIOLOGICAL CONTAMINATION SEEN IN MULTIPLE BOTTLES SHOWING A SLOW GROWING GRAM NEGATIVE BACILLI CONSISTENT WITH BURKHOLDERIA/PARABURKHOLDERIA SPECIES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
IT WAS REPORTED THAT WHEN USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS BIOLOGICAL CONTAMINATION SEEN IN TWO BOTTLES SHOWING A SLOW GROWING GRAM-NEGATIVE BACILLI CONSISTENT WITH BURKHOLDERIA/PARABURKHOLDERIA SPECIES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
IT WAS REPORTED WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC), THERE WAS A FALSE RESULT DUE TO CONTAMINATION. THERE WAS NO REPORT OF PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2279452 | BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) | SYSTEM, BLOOD CULTURING | MDB | BECTON DICKINSON CARIBE LTD. | 4171480 | 00382904420239 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |