BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM PRO 100 BOX 1200 US

    MDR report key: 19136201 · Received April 18, 2024

    Report

    Report Number
    9616656-2024-05270
    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
    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

    5 PEN NEEDLES AFFECTED BY EVENT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO: B4, G6, H2, H3, H11. MEDWATCH SECTION C FOR THE AFFECTED PRODUCT IS ATTACHED. 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 AND BROKEN CANNULA NPE. 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 REPORTED FOUND 5 PEN NEEDLES THAT CLOGGED DURING INJECTION. INFORMED CALLER TO COMPLETE FLOW CHECK. CONSUMER REPORTED WHILE ON THE PHONE NON PATIENT END IS BENT ALL 5 THAT CLOGGED. LOT # 3101689 CATALOG# 320550 DATE OF EVENT UNKNOWN SAMPLE STATUS AWAITING SAMPLE - DC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2309702 PEN NDL 32G 4MM PRO 100 BOX 1200 US NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND 320550 3101689 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown