BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM PRO 100 BOX 1200 US

    MDR report key: 18646181 · Received February 5, 2024

    Report

    Report Number
    9616656-2024-05061
    Event Type
    Malfunction
    Date Received
    February 5, 2024
    Report Date
    April 30, 2024
    Manufacturer
    BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K212015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : DEVICE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO: G6, H2, H3, H6, H10 INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THIS IS THE 6TH 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 NEEDLE CLOG DURING INJECTION, STATED THAT THERE IS NO INSULIN FLOW. CONSUMER DOES NOT RE-USE. CONSUMER WAS RUDE, STARTED YELLING AND WOULD NOT ALLOW ME TO SPEAK. AFTER YELLING, SHE DISCONNECTED THE CALL. SHE REFUSED REPLACEMENT, STATED THAT SHE HAS PLENTY OF NEEDLES. CONSUMER ALSO REFUSED TO SEND SAMPLES. LOT #: 0231157. CATALOG #: 320550. DATE OF EVENT: UNKNOWN. SAMPLES: DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2091195 PEN NDL 32G 4MM PRO 100 BOX 1200 US NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND 320550 0231157 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown