BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 31GA 5MM 100BX 1200 USA

    MDR report key: 19134076 · Received April 18, 2024

    Report

    Report Number
    9616656-2024-05265
    Event Type
    Malfunction
    Date Received
    April 18, 2024
    Report Date
    July 11, 2024
    Manufacturer
    BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND
    Product Code
    FMI
    UDI-DI
    00382903201198
    PMA / PMN Number
    K213478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO: B4, G6, H2, H3, H11. CORRECTION TO: D3 (COUNTRY TYPE AND COUNTRY), H6 (COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS). INVESTIGATION SUMMARY: SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. 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. EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE AS BENT CANNULA PE. BASED ON TREND ANALYSIS NO FURTHER ACTION IS REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED.

    Description of Event or Problem · 0

    CONSUMER HAS DIFFICULTY REMOVING THE NEEDLE FROM THE PEN AFTER HIS INJECTION. HE STATED THAT WHEN HE TRIES TO PUT THE OUTER COVER BACK ONTO THE HUB, THE COVER DOES NOT FIT SECURELY AND IT FALLS OFF. CONSUMER DOES NOT RE-USE. BUT HE STORES NEEDLE ON HIS PEN AT TIMES. LOT #: 2130196. CATALOG #: 320119 DATE OF EVENT: UNKNOWN. SAMPLES: AWAITING SAMPLE. DC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2237717 PEN NDL 31GA 5MM 100BX 1200 USA NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND 320119 2130195 00382903201198

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown