BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)
Report
- Report Number
- 2647876-2024-00166
- Event Type
- Malfunction
- Date Received
- November 26, 2024
- Date of Event
- September 25, 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: 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 BATCH HAS BEEN PREVIOUSLY INVESTIGATED FOR THE REPORTED DEFECT. 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 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 FIELDS HAVE BEEN UPDATED: B5. IT WAS REPORTED THAT WHEN USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS BIOLOGICAL CONTAMINATION FOR ONE BOTTLE. STATE DEPARTMENT IDENTIFIED PARABURKHOLDERIA FUNGORUM. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THIS SUPPLEMENTAL MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING APRIL 2023¿2025, UNDER CAPA 11910483.
IT WAS REPORTED THAT WHEN USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) THERE WAS BIOLOGICAL CONTAMINATION SEEN IN TWO BOTTLES. STATE DEPARTMENT IDENTIFIED PARABURKHOLDERIA FUNGORUM. 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. STATE DEPARTMENT IDENTIFIED PARABURKHOLDERIA FUNGORUM. 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 FOR ONE BOTTLE. STATE DEPARTMENT IDENTIFIED PARABURKHOLDERIA FUNGORUM. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2368775 | 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 |