BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMALE LL ADAPTOR

    MDR report key: 11968980 · Received June 9, 2021

    Report

    Report Number
    1911916-2021-00537
    Event Type
    Malfunction
    Date Received
    June 9, 2021
    Date of Event
    May 13, 2021
    Report Date
    July 27, 2021
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: FIVE PHOTOS OF FEMALE LUER LOCK ADAPTORS, MODEL 1022-085-032, WAS RETURNED BY THE CUSTOMER. THE REPORTED CRACKS COULD VISUALLY BE CONFIRMED. NO PHYSICAL SAMPLES WERE RETURNED FOR ADDITIONAL INVESTIGATION, HOWEVER, THE CUSTOMER STATED THAT "THE SAMPLES WERE USED BY OUR ENGINEERS TO TRY TO FIGURE OUT THE CAUSE OF THIS REJECTION, BUT THEY FELT THAT THIS WAS AN INTERNAL ERROR SOMEWHERE ALONG IN OUR PROCESS WITH NEW OPERATORS." TO CONFIRM THAT OUR PROCESS DID NOT CONTRIBUTE TO THE REPORTED DEFECT, A DHR REVIEW WAS PERFORMED BY NAMC. 944 SAMPLES WERE VISUALLY INSPECTED WITH ZERO NON-CONFORMITIES FOUND. 112 SAMPLES WERE TESTED FOR MATERIAL STRENGTH WITH ZERO NON-CONFORMITIES FOUND. A QN QUERY FOR THE OCCLUSION ISSUE ON PART 1022-085-032 WAS RUN, AND NO HISTORY OF THE DEFECT WAS FOUND. THEREFORE, THIS IS CONCLUDED AS A NON-RECURRING ISSUE. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FEMALE LL ADAPTOR HAD CRACKS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THEY ARE FINDING CRACKS IN THE LEURS.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: NA. 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 · 1

    IT WAS REPORTED THAT FEMALE LL ADAPTOR HAD CRACKS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THEY ARE FINDING CRACKS IN THE LEURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865962 FEMALE LL ADAPTOR INTRAVASCULAR ADMINISTRATION SET FPA 0348001

    Patients

    Seq Age Sex Outcome Treatment
    1