BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAY SPN WHIT25G3.5 L/B-D/E

    MDR report key: 11586625 · Received March 29, 2021

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    Report

    Report Number
    2243072-2021-00897
    Event Type
    Malfunction
    Date Received
    March 29, 2021
    Date of Event
    February 26, 2021
    Report Date
    September 24, 2021
    Product Code
    CAZ
    UDI-DI
    00382904056735
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: NO SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND FOR THE REPORTED LOT NUMBERS WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THE REPORTED INCIDENT WERE FOUND. THE COMPONENT INVOLVED IS PROVIDED BY A SUPPLIER WHOM WE HAVE NOTIFIED OF THIS INCIDENT INITIATED AN INVESTIGATION REQUEST. WHILE WE DID NOT HAVE A PHYSICAL SAMPLE, WE ROUTINELY PERFORM EVALUATIONS TO ENSURE OUR MANUFACTURING PROCESS DOES NOT IMPACT THE POTENCY OF THE DRUG PROVIDED WITHIN THE KIT, RESULTS WERE REVIEWED AND ALL RESULTS WERE FOUND TO BE ACCEPTABLE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED FOR FUTURE OCCURRENCE. FAILURE COULD NOT BE CONFIRMED AS A MANUFACTURING RELATED DEFECT (INVESTIGATION INCONCLUSIVE). AS A RESULT, CAPA/SA DETERMINATION = NOT REQUIRED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TRAY SPN WHIT25G3.5 L/B-D/E WAS NOT WORKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 405673 BACK NO.: UNKNOWN (1387545 OR 1370473. IT WAS REPORTED THAT THE ANESTHESIA IN THE TRAYS ARE NOT WORKING.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS HDQ US FRANKLIN LAKES. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. THE CUSTOMER'S ADDRESS IS UNKNOWN. NEW JERSEY (NJ), USA HAS BEEN USED AS A DEFAULT. PMA/510(K)#: ENFORCEMENT DISCRETION. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TRAY SPN WHIT25G3.5 L/B-D/E WAS NOT WORKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 405673 ,BACK NO.: UNKNOWN (1387545 OR 1370473). IT WAS REPORTED THAT THE ANESTHESIA IN THE TRAYS ARE NOT WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480810 TRAY SPN WHIT25G3.5 L/B-D/E ANESTHESIA CONDUCTION KIT CAZ 405673 UNKNOWN 00382904056735

    Patients

    Seq Age Sex Outcome Treatment
    1