BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ GASPAK¿ 100 ANAEROBIC SYSTEM

    MDR report key: 16513363 · Received March 9, 2023

    Report

    Report Number
    1119779-2023-00262
    Event Type
    Malfunction
    Date Received
    March 9, 2023
    Date of Event
    February 15, 2023
    Report Date
    April 29, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    KZJ
    UDI-DI
    00382902606260
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: A COMPLAINT INVESTIGATION DUE TO GROWTH FAILURE ON GASPAK 100 SYSTEM CATALOG 260629 WAS PERFORMED. RETURNED GOODS WERE NOT RECEIVED FROM CUSTOMER. THE INVESTIGATION REQUIRED TO EVALUATE QN AND COMPLAINT HISTORY. NO TREND WAS OBSERVED IN A PERIOD OF ONE YEAR. BATCH RECORD REVIEW UNABLE TO INVESTIGATE DUE TO BATCH NUMBER WAS NOT RECEIVED FROM CUSTOMER. NO CORRECTIVE ACTION IS REQUIRED BASED ON INFORMATION EVALUATED. 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

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BBL¿ GASPAK¿ 100 ANAEROBIC SYSTEM EXPERIENCING GROWTH ISSUES WHEN USING GASPAK SYSTEM. NO INJURIES WERE REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THEY ARE EXPERIENCING GROWTH ISSUES WHEN USING THE GASPAK SYSTEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD BBL¿ GASPAK¿ 100 ANAEROBIC SYSTEM EXPERIENCING GROWTH ISSUES WHEN USING GASPAK SYSTEM. NO INJURIES WERE REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THEY ARE EXPERIENCING GROWTH ISSUES WHEN USING THE GASPAK SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140869 BD BBL¿ GASPAK¿ 100 ANAEROBIC SYSTEM DEVICE, GAS GENERATING KZJ BECTON, DICKINSON & CO. (SPARKS) 260626 UNKNOWN 00382902606260

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown