BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG

    MDR report key: 19083523 · Received April 10, 2024

    Report

    Report Number
    1920898-2024-05079
    Event Type
    Malfunction
    Date Received
    April 10, 2024
    Date of Event
    March 16, 2024
    Report Date
    July 25, 2024
    Manufacturer
    BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949
    Product Code
    FMF
    UDI-DI
    00382903249091
    PMA / PMN Number
    K212499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO (TYPE OF INVESTIGATION). INVESTIGATION SUMMARY NOT AVAILABLE YET. ONCE THE INVESTIGATION IS COMPLETED. INVESTIGATION SUMMARY WILL BE PROVIDED.

    Additional Manufacturer Narrative · 0

    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. A PROCESS NON-CONFORMANCE 200000067 HAS BEEN OPENED FOR THE LINE CLEARANCE AND CHANGE OVER DOCUMENTATION TO INVESTIGATE IMPROVEMENTS OF THE PROCESS. AN INITIATIVE TO REDUCE THE FREQUENCY OF PRODUCT MIX INCIDENTS BY MITIGATING FAULTS CAUSED BY LINE CLEARANCES HAS BEEN STARTED AS PART OF THE MANUFACTURING PLANTS FOCUSED IMPROVEMENT EFFORTS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED AND MONITORED ON TREND REPORTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA TO IDENTIFY EMERGING TRENDS. BASED ON THE ABOVE, NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED.

    Description of Event or Problem · 0

    CONSUMER REPORTED, SHE FOUND ONE SYRINGE IN HER PACK WITH "SCALE MARKINGS IN RED INK" AND SYRINGE SAID, "U-40" AND MARKINGS WERE COUNTING BY "TWO'S". STATED, THE REMAINING SYRINGES SHE HAS IN PACKAGE AND BOX, THE SCALE MARKINGS ARE "BLACK INK" AND IS U-100. STATED, SHE DID NOT USE THE SYRINGE THAT WAS IN RED. WANTED TO FIND OUT FIRST IF IT WAS OKAY TO USE. 1 SYRINGE AFFECTED LOT: 2213816 CATALOG: 324909 DATE OF EVENT: 2024-03-16 SAMPLE: YES CL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1800549 SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG SYRINGE, PISTON FMF BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949 324909 2213816 00382903249091

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown