BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC)

    MDR report key: 14401782 · Received May 13, 2022

    Report

    Report Number
    2647876-2022-00138
    Event Type
    Malfunction
    Date Received
    May 13, 2022
    Date of Event
    April 18, 2022
    Report Date
    July 5, 2022
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420215
    PMA / PMN Number
    K123903
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. INITIAL REPORTER ADDRESS: (B)(6). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D4: MEDICAL DEVICE LOT #: 2041452. D4: MEDICAL DEVICE EXPIRATION DATE: 2022-12-31. H4: DEVICE MANUFACTURE DATE: 2022-02-10. D4: MEDICAL DEVICE LOT #: 1327339. D4: MEDICAL DEVICE EXPIRATION DATE: 2022-09-30. H4: DEVICE MANUFACTURE DATE: 2021-11-23. D4: MEDICAL DEVICE LOT #: 1194059. D4: MEDICAL DEVICE EXPIRATION DATE: 2022-04-30. H4: DEVICE MANUFACTURE DATE: 2021-07-13. D4: MEDICAL DEVICE LOT #: 2041457. D4: MEDICAL DEVICE EXPIRATION DATE: 2022-12-31. H4: DEVICE MANUFACTURE DATE: 2022-02-10. D4: MEDICAL DEVICE LOT #: 1270310. D4: MEDICAL DEVICE EXPIRATION DATE: 2022-07-31. H4: DEVICE MANUFACTURE DATE: 2021-09-27. D4: MEDICAL DEVICE LOT #: 1259112. D.4. MEDICAL DEVICE EXPIRATION DATE: 2022-06-30. H4: DEVICE MANUFACTURE DATE: 2021-09-16. D4: MEDICAL DEVICE LOT #: 1273788. D4: MEDICAL DEVICE EXPIRATION DATE: 2022-07-31. H4: DEVICE MANUFACTURE DATE: 2021-09-30.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: CATALOG 442023. BATCH NO. 2041452, 1327339, 2041457, 1270310 & 1273788. CUSTOMER REPORTED A CONTAMINATION ISSUE WHILE USING BACTEC PRODUCT. NEITHER PHOTOS NOR RETURNED GOOD SAMPLES WERE RECEIVED. 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. 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. PRODUCT INSERT WARNINGS AND PRECAUTIONS SECTIONS STATES THAT PRIOR TO USE, EACH VIAL SHOULD BE EXAMINED FOR EVIDENCE OF CONTAMINATION SUCH AS CLOUDINESS, BULGING OR DEPRESSES SEPTUM, OR LEAKAGE. VIALS SHOWING EVIDENCE OF CONTAMINATION SHOULD NOT BE USED. ALSO PRIOR TO USE, THE USER SHOULD EXAMINE THE VIAL FOR EVIDENCE OF DAMAGE OR DETERIORATION. VIALS DISPLAYING TURBIDITY, CONTAMINATION, OR DISCOLORATION (DARKENING) SHOULD NOT BE USED. 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. UNKNOWN . CUSTOMER REPORTED A CONTAMINATION ISSUE WHILE USING BACTEC PRODUCT. NEITHER PHOTOS NOR RETURNED GOOD SAMPLES WERE RECEIVED. BD WAS NOT ABLE TO PERFORM AN INVESTIGATION TO THE RETENTION SAMPLES SINCE BATCH 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. PRODUCT INSERT WARNINGS AND PRECAUTIONS SECTIONS STATES THAT PRIOR TO USE, EACH VIAL SHOULD BE EXAMINED FOR EVIDENCE OF CONTAMINATION SUCH AS CLOUDINESS, BULGING OR DEPRESSES SEPTUM, OR LEAKAGE. VIALS SHOWING EVIDENCE OF CONTAMINATION SHOULD NOT BE USED. ALSO PRIOR TO USE, THE USER SHOULD EXAMINE THE VIAL FOR EVIDENCE OF DAMAGE OR DETERIORATION. VIALS DISPLAYING TURBIDITY, CONTAMINATION, OR DISCOLORATION (DARKENING) SHOULD NOT BE USED. COMPLAINT IS UNCONFIRMED. NO CORRECTIVES 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 INVESTIGATION PROCESS. CATALOG 442021. BATCH NO. 1259112. CUSTOMER REPORTED A CONTAMINATION ISSUE WHILE USING BACTEC PRODUCT. NEITHER PHOTOS NOR RETURNED GOOD SAMPLES WERE RECEIVED. RETENTION SAMPLES COULD NOT BE VISUALLY INSPECTED/ TESTED FOR REPORTED DEFECT. BATCH HISTORY RECORD REVIEW WAS USED FOR THIS INVESTIGATION. BATCH/SENSOR HISTORY RECORDS WERE REVIEWED, AND ALL TESTING WERE WITHIN SPECIFICATION FOR PRODUCT RELEASE. 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 BATCH HISTORY RECORD REVIEW. PRODUCT INSERT WARNINGS AND PRECAUTIONS SECTIONS STATES THAT PRIOR TO USE, EACH VIAL SHOULD BE EXAMINED FOR EVIDENCE OF CONTAMINATION SUCH AS CLOUDINESS, BULGING OR DEPRESSES SEPTUM, OR LEAKAGE. VIALS SHOWING EVIDENCE OF CONTAMINATION SHOULD NOT BE USED. ALSO PRIOR TO USE, THE USER SHOULD EXAMINE THE VIAL FOR EVIDENCE OF DAMAGE OR DETERIORATION. VIALS DISPLAYING TURBIDITY, CONTAMINATION, OR DISCOLORATION (DARKENING) SHOULD NOT BE USED. 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. 1194059 EXPIRED. CUSTOMER REPORTED A CONTAMINATION ISSUE WHILE USING BACTEC PRODUCT. NEITHER PHOTOS NOR RETURNED GOOD SAMPLES WERE RECEIVED. UPON FURTHER EVALUATION IT WAS NOTICED THAT COMPLAINT RECEIVED WAS FROM A PRODUCT ALREADY EXPIRED. NO INVESTIGATION CAN BE CONDUCTED TO THE RETENTION SAMPLES. 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. PRODUCT INSERT WARNINGS AND PRECAUTIONS SECTIONS STATES THAT PRIOR TO USE, EACH VIAL SHOULD BE EXAMINED FOR EVIDENCE OF CONTAMINATION SUCH AS CLOUDINESS, BULGING OR DEPRESSES SEPTUM, OR LEAKAGE. VIALS SHOWING EVIDENCE OF CONTAMINATION SHOULD NOT BE USED. ALSO PRIOR TO USE, THE USER SHOULD EXAMINE THE VIAL FOR EVIDENCE OF DAMAGE OR DETERIORATION. VIALS DISPLAYING TURBIDITY, CONTAMINATION, OR DISCOLORATION (DARKENING) SHOULD NOT BE USED. THE SPECIMEN MUST BE COLLECTED USING STERILE TECHNIQUES TO REDUCE THE CHANCE OF CONTAMINATION. DO NOT USE CULTURE VIALS PAST THEIR EXPIRATION DATE. COMPLAINT IS UNCONFIRMED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) THE CUSTOMER SUSPECTED BIOLOGICAL CONTAMINATION OF THE MEDIA. THIS EVENT OCCURRED 24 TIME(S). THERE IS NO INDICATION THAT FALSE RESULTS WERE REPORTED TO HEALTH CARE PRACTITIONERS. THERE IS NO INDICATION OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER IS REPORTING SUSPECTED CONTAMINATION WITH BACTEC BOTTLES", "SEQUENCE NUMBERS OF POSSIBLY AFFECTED 442021 BOTTLES. 24 TOTAL: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) THE CUSTOMER SUSPECTED BIOLOGICAL CONTAMINATION OF THE MEDIA. THIS EVENT OCCURRED 24 TIME(S). THERE IS NO INDICATION THAT FALSE RESULTS WERE REPORTED TO HEALTH CARE PRACTITIONERS. THERE IS NO INDICATION OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER IS REPORTING SUSPECTED CONTAMINATION WITH BACTEC BOTTLES", "SEQUENCE NUMBERS OF POSSIBLY AFFECTED 442021 BOTTLES. 24 TOTAL: 446582125123, 446563957893, 446563957853, 446597080119, 446597080288, 446597080151, 446597080287, 446596790040, 446597079150, 446597079177, 446580923474, 446580923475, 446554139341, 446554377874, 446554139341, 446553739026, 446554139301, 446554139253, 446557684814, 446553768637, 446555581894, 446553768637, 446554377875, 446561855036."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) THE CUSTOMER SUSPECTED BIOLOGICAL CONTAMINATION OF THE MEDIA. THIS EVENT OCCURRED 24 TIME(S). THERE IS NO INDICATION THAT FALSE RESULTS WERE REPORTED TO HEALTH CARE PRACTITIONERS. THERE IS NO INDICATION OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER IS REPORTING SUSPECTED CONTAMINATION WITH BACTEC BOTTLES", "SEQUENCE NUMBERS OF POSSIBLY AFFECTED 442021 BOTTLES. 24 TOTAL: (B)(6)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1395608 BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 442021 SEE H10 00382904420215

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown