BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE¿+ INSULIN SYRINGE

    MDR report key: 16873067 · Received May 4, 2023

    Report

    Report Number
    1920898-2023-00276
    Event Type
    Malfunction
    Date Received
    May 4, 2023
    Date of Event
    April 13, 2023
    Report Date
    August 3, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, 23-JUN-2023. D10: RETURNED TO MANUFACTURER ON: H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED ONE OF 0.5ML 30GA 8MM SYRINGE INSIDE AN OPEN PACKAGING. FROM THE LOT# 0160047. THE RUBBER STOPPER IS MELTED. WHEN THEY OPENED THE CONTAINER, THEY FOUND THAT THE STOPPER OF THE SYRINGE WAS MELTED. RETURNED SAMPLE WAS VISUALLY EXAMINED AND OBSERVED THAT THE STOPPER WAS DAMAGED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0160047. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER INDICATED FAILURE.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RUBBER STOPPER IN THE BD MICRO-FINE¿+ INSULIN SYRINGE MELTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH: "THE RUBBER STOPPER IS MELTED. WHEN THEY OPENED THE CONTAINER THEY FOUND THAT THE STOPPER OF THE SYRINGE WAS MELTED. WE CALL THE CUSTOMER TO ASK IF IT IS INK, BUT HE CONFIRMS THAT IT IS THE MELTED RUBBER. ON THE OTHER HAND, WE MAKE SURE THAT IT DOES NOT COME OFF THE SAMPLE. BEFORE USE".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RUBBER STOPPER IN THE BD MICRO-FINE¿+ INSULIN SYRINGE MELTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH: "THE RUBBER STOPPER IS MELTED. WHEN THEY OPENED THE CONTAINER THEY FOUND THAT THE STOPPER OF THE SYRINGE WAS MELTED. WE CALL THE CUSTOMER TO ASK IF IT IS INK, BUT HE CONFIRMS THAT IT IS THE MELTED RUBBER. ON THE OTHER HAND, WE MAKE SURE THAT IT DOES NOT COME OFF THE SAMPLE. BEFORE USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713887 BD MICRO-FINE¿+ INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 0160047

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown