BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 31G TW 6MM BLS 400 SG

    MDR report key: 21023889 · Received December 26, 2024

    Report

    Report Number
    3024508819-2024-00512
    Event Type
    Malfunction
    Date Received
    December 26, 2024
    Report Date
    February 13, 2025
    Manufacturer
    EMBECTA MEDICAL I LLC - HOLDREGE, NE
    Product Code
    FMF
    PMA / PMN Number
    K992734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO: B4, G6, H2, H3, H11. CORRECTION TO: H6 (COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS). INVESTIGATION SUMMARY: NO SAMPLES WERE RETURNED THEREFORE THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTO(S) PROVIDED. EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER-INDICATED ISSUE. 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

    MATERIAL # 328447. MATERIAL DESCRIPTION - SYRINGE 0.5ML 31G TW 6MM BLS 400 SG. MATERIAL LOT# - 4103061. COMPLAINT DESCRIPTION ¿ OUR NURSES AT (B)(6) HOSPITAL IN (B)(6), NY ARE SEEING A CONCERN WITH OUR CURRENT INSULIN SYRINGE, REF# (B)(4), LOT# 4103061P1. PLEASE SEE THE ATTACHED PHOTOS OF WHAT APPEARS TO BE DOUBLE INK MARKS FOR UNIT MARKINGS. THIS PRESENTS A SAFETY ISSUE FOR DOSING. WANTED TO MAKE YOU AWARE THAT ONE OF OUR NURSES NOTICED SEVERAL OF OUR INSULIN NEEDLES HAVE A FAINT DOUBLE PRINT ON THEM, WHICH COULD BE DANGEROUS FOR INSULIN ADMINISTRATION. I HAVE A FEW OF THEM IN MY OFFICE WITH THE PACKAGING IF YOU NEED THEM. NOTES (IF ANY) ¿ ATTACHING THE PHOTOS THAT CUSTOMER HAS PROVIDED FOR FURTHER REFERENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2510599 SYRINGE 0.5ML 31G TW 6MM BLS 400 SG SYRINGE, PISTON FMF EMBECTA MEDICAL I LLC - HOLDREGE, NE 328447 4103061

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose