BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 30GA 1/2IN UF 10BAG 500CS

    MDR report key: 19130838 · Received April 18, 2024

    Report

    Report Number
    1920898-2024-05100
    Event Type
    Malfunction
    Date Received
    April 18, 2024
    Date of Event
    January 23, 2024
    Report Date
    July 9, 2024
    Manufacturer
    BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949
    Product Code
    FMF
    UDI-DI
    00382908411035
    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

    6 SYRINGES AFFECTED BY EVENT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED TO SECTIONS B4, G6, H2, H3, AND H11. SEE MEDWATCH COMPLETED SECTION C FORM ATTACHED. CORRECTIONS MADE TO SECTION H6 (COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, & 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 AND 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 6 NEEDLE SHIELD LAYING IN 1 SEALED SYRINGE PACKET. 5 OF THE 6 HAD THE NEEDLES STUCK IN THE SHIELDS. AND 1 SYRINGE HAD THE NEEDLE ATTACHED TO THE SYRINGE WITH JUST THE EMPTY SHIELD IN THE BAG. NO INJURY FROM THIS INCIDENT. DC LOT # 3100603 CATALOG# 328411 DATE OF EVENT (B)(6) 2024 SAMPLE STATUS AWAITING SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540483 SYRINGE 1.0ML 30GA 1/2IN UF 10BAG 500CS SYRINGE, PISTON FMF BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949 328411 3100603 00382908411035

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown