BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD GASPAK¿ EZ ANAEROBE CONTAINER SYSTEM

    MDR report key: 16550412 · Received March 15, 2023

    Report

    Report Number
    1119779-2023-00289
    Event Type
    Malfunction
    Date Received
    March 15, 2023
    Date of Event
    March 3, 2023
    Report Date
    April 29, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    KZJ
    UDI-DI
    30382902606780
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: A COMPLAINT INVESTIGATION DUE TO INCORRECT LABELING ON GASPAK EZ ANAEROBE CONTAINER CATALOG 260678 BATCH NO.: 2055996 WAS PERFORMED ON RETENTION SAMPLES. RETURNED GOODS WERE NOT RECEIVED FROM CUSTOMER. THE INVESTIGATION REQUIRED TO PERFORM VISUAL INSPECTION, INCOMING AND BATCH RECORD REVIEW. NO DISCREPANCIES OBSERVED DURING THE VISUAL INSPECTION. BATCH RECORD REVIEW DID NOT SHOW ANY EVIDENCE OF CUSTOMER CLAIM. INCOMING RECORD NOT AVAILABLE, LOT RECEIVED UNDER SKIP LOT PROGRAM. PHOTO RECEIVED FROM CUSTOMER WAS EVALUATED. NO DISCREPANCY OBSERVED. RAW MATERIAL BATCH NUMBER 1272LJ WAS USED TO MANUFACTURE BD BATCH 2055996. NO CORRECTIVE ACTION IS REQUIRED BASED ON INFORMATION EVALUATED AND SATISFACTORY RESULTS OBTAINED DURING THE QC TEST. COMPLAINT IS NOT CONFIRMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE #: (B)(6). INITIAL REPORTER ADDR 1: (B)(6). 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 WHILE USING THE BD GASPAK¿ EZ ANAEROBE CONTAINER SYSTEM THAT THERE WAS A LABEL ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONFIRM IF THE LOT OF THE BOX AND LOT OF THE ENVELOPES IN THE CATALOG IS NORMAL THAT THEY ARE NOT THE SAME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD GASPAK¿ EZ ANAEROBE CONTAINER SYSTEM THAT THERE WAS A LABEL ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONFIRM IF THE LOT OF THE BOX AND LOT OF THE ENVELOPES IN THE CATALOG IS NORMAL THAT THEY ARE NOT THE SAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768792 BD GASPAK¿ EZ ANAEROBE CONTAINER SYSTEM DEVICE, GAS GENERATING KZJ BECTON, DICKINSON & CO. (SPARKS) 260678 2055996 30382902606780

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown