BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD GASPAK¿ EZ ANAEROBE CONTAINER SYSTEM WITH INDICATOR

    MDR report key: 14580232 · Received June 2, 2022

    Report

    Report Number
    2647876-2022-00152
    Event Type
    Malfunction
    Date Received
    June 2, 2022
    Date of Event
    May 24, 2022
    Report Date
    August 29, 2022
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    KZJ
    UDI-DI
    30382902600016
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY CUSTOMER COMPLAINED THAT GASPAK EZ CONTAINER CATALOG 260001 SHOWED CONTAMINATION (BLACK SPOT). PHOTOS RECEIVED FROM CUSTOMER WERE EVALUATED. BLACK SPOT OBSERVED. THIS IS CONSIDERED COSMETIC DEFECT AND DO NOT AFFECT PRODUCT PERFORMANCE. RETENTION SAMPLES DID NOT SHOWED EVIDENCE OF CUSTOMER CLAIM. BASED ON INFORMATION EVALUATED, THIS COMPLAINT IS CONFIRMED. COMPLAINT WILL BE MONITORED FOR TREND.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD GASPAK¿ EZ ANAEROBE CONTAINER SYSTEM WITH INDICATOR WERE CONTAMINATED. THERE WAS NO REPORT OF CONFIRMATORY TESTING. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD GASPAK¿ EZ ANAEROBE CONTAINER SYSTEM WITH INDICATOR WERE CONTAMINATED. THERE WAS NO REPORT OF CONFIRMATORY TESTING. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT HAS BEEN REPORTED THAT THE CUSTOMER HAS OPENED THE BOXES TO FIND SACHETS WITH CONTAMINANTS ON THE OUTSIDE. THE CUSTOMER HAS REMOVED THE WHOLE BATCH FROM USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865255 BD GASPAK¿ EZ ANAEROBE CONTAINER SYSTEM WITH INDICATOR DEVICE, GAS GENERATING KZJ BECTON DICKINSON CARIBE LTD. 260001 2007637 30382902600016

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown