BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 30GA 1/2IN UF 10BAG 500CS

    MDR report key: 18836815 · Received March 5, 2024

    Report

    Report Number
    1920898-2024-05048
    Event Type
    Malfunction
    Date Received
    March 5, 2024
    Report Date
    May 28, 2024
    Manufacturer
    BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949
    Product Code
    FMF
    UDI-DI
    00382908466035
    PMA / PMN Number
    K190054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    CORRECTION TO H6, TYPE OF INVESTIGATION, INVESTIGATION CONCLUSIONS. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THIS IS THE 1ST COMPLAINT FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED, AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    CONSUMER REPORTED THAT THE SCALE PRINT IS CROOKED. CONSUMER ALSO REPORTED RUBBER STOPPER IS SLANTED IN THE BARREL. CONSUMER REFUSED TO SEND IN SAMPLES, STATED THAT HE DID THIS BEFORE AND THE PROBLEM HAS NOT BEEN FIXED. CONSUMER DISCONNECTED THE CALL. LOT #: 3202457 CATALOG #: 328466 DATE OF EVENT: UNKNOWN SAMPLES: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196959 SYRINGE 0.5ML 30GA 1/2IN UF 10BAG 500CS SYRINGE, PISTON FMF BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949 328466 3202457 00382908466035

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown