BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)

    MDR report key: 12807687 · Received November 12, 2021

    Report

    Report Number
    2647876-2021-00276
    Event Type
    Malfunction
    Date Received
    November 12, 2021
    Date of Event
    October 18, 2021
    Report Date
    December 27, 2021
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420239
    PMA / PMN Number
    K113558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CATALOG 442023; BATCH NO. 1068275. CUSTOMER REPORTED A MISSING/DETACHED FLIP-OFF CAP DEFECT. PHOTOS WERE NOT PROVIDED. BD WAS UNABLE TO REPRODUCE CUSTOMER'S EXPERIENCE WITH THE BACTEC PRODUCT. SATISFACTORY RESULTS WERE OBTAINED FROM RETENTION SAMPLES WHEN VISUALLY INSPECTED FOR MISSING/DETACHED FLIP-OFF CAP DEFECT. 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. BATCH HISTORY RECORD REVIEW DID NOT IDENTIFY ANY EVIDENCE FOR WHICH THE CUSTOMER SUBMITTED THE COMPLAINT. COMPLAINT UNCONFIRMED BASED ON RETENTION SAMPLES AND BATCH HISTORY RECORDS REVIEW RESULTS. CONTROLS IN PLACE TO DETECT THIS TYPE OF DEFECTS ARE: AN ON-LINE VISUAL INSPECTION IS PERFORMED TO ALL BOTTLES BEFORE BEING LABELED FOR PRESENCE OF FLIP CAP. IF ANY BOTTLE IS DETECTED, IT IS REMOVED. AN AUTOMATED 100% INSPECTION IS PERFORMED TO THE BOTTLES AFTER BEING LABELED FOR PRESENCE OF FLIP CAP. IF THE SYSTEM DETECTS ANY DEFECTIVE BOTTLE, IT IS REJECTED. DURING THE PACKAGING PROCESS OF EACH LOT, A PROCESS CONTROL REPRESENTATIVE INSPECTS 1 CASE EVERY 30 MINUTES FOR COMPLETENESS. NO CORRECTIVE ACTION WAS 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 442023; BATCH NO. 1132369. CUSTOMER REPORTED A VIAL LABEL DAMAGE, ONE PHOTO WAS PROVIDED. BD WAS UNABLE TO REPRODUCE CUSTOMER EXPERIENCE WITH THE BACTEC PRODUCT. SATISFACTORY RESULTS WERE OBTAINED FROM RETENTION SAMPLES WHEN VISUALLY INSPECTED FOR DAMAGE LABEL. 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 CONFIRMED BASED ON PHOTOS RECEIVED. TECHNICAL ASSESSMENT WAS PERFORMED TO DETERMINE IF THE WEILER LABELER HAD MECHANICAL ISSUES AND/OR BREAKDOWNS DURING THE MANUFACTURING PROCESS OF THE AFOREMENTIONED BATCH. PREVENTIVE MAINTENANCE ACTIVITIES TO THE LABELER MACHINE WERE COMPLETED ON TIME AS SCHEDULED. UPON EVALUATION OF BREAKDOWNS / INCIDENTS REPORTS, THERE WERE NO MALFUNCTIONS OR ISSUES RELATED TO DAMAGED LABELS PRODUCTION REPORTS WERE EVALUATED AND NO ISSUES RELATED TO DAMAGED LABELS WERE DOCUMENTED. THE LABELER WAS FOUND WORKING AS EXPECTED. NO TREND HAVE BEEN IDENTIFIED FOR REPORTED DEFECT. 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. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1132369, MEDICAL DEVICE EXPIRATION DATE: 2022-02-28, DEVICE MANUFACTURE DATE: 2021-05-12. MEDICAL DEVICE LOT #: 1068275, MEDICAL DEVICE EXPIRATION DATE: 2021-12-31, DEVICE MANUFACTURE DATE: 2021-03-09. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) EXPERIENCED MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM JAPANESE TO ENGLISH: ACCORDING TO THE CUSTOMER¿S REPORT, THERE WAS A BOTTLE WITH A DEFECTIVE LABEL AND ANOTHER WITH A DETACHED CAP. THE GRAY CAP WAS DETACHED UPON ARRIVAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) EXPERIENCED MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM (B)(6) TO ENGLISH: ACCORDING TO THE CUSTOMER¿S REPORT, THERE WAS A BOTTLE WITH A DEFECTIVE LABEL AND ANOTHER WITH A DETACHED CAP. THE GRAY CAP WAS DETACHED UPON ARRIVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1704420 BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 442023 SEE H10 00382904420239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown