BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31G 6MM S/C U-100 RELION

    MDR report key: 11228118 · Received January 25, 2021

    Report

    Report Number
    1920898-2021-00105
    Event Type
    Malfunction
    Date Received
    January 25, 2021
    Date of Event
    January 5, 2021
    Report Date
    February 26, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMI
    UDI-DI
    00681131138383
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 0132212 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WAS ONE (1) NOTIFICATION NOTED FOR RAISED SHIELDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SYRINGE 0.3ML 31G 6MM S/C U-100 RELION HAD THE SHIELD NOT ABLE TO DETACH DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT NEEDLE SHIELDS ARE DIFFICULT TO REMOVE AND ALSO NEEDLES WERE MISSING FROM SYRINGES. VERBATIM: CONSUMER REPORTED THAT THE NEEDLE SHIELD IS DIFFICULT TO REMOVE. ALSO REPORTED NEEDLE MISSING FROM SYRINGES, STATED THAT THE NEEDLE HUB IS INTACT. LOT #: 0132212. CATALOG #: 328521. DATE OF EVENT: UNKNOWN. SAMPLES: DISCARDED."

    Additional Manufacturer Narrative · 1

    "DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4)".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYRINGE 0.3ML 31G 6MM S/C U-100 RELION HAD THE SHIELD NOT ABLE TO DETACH DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT NEEDLE SHIELDS ARE DIFFICULT TO REMOVE AND ALSO NEEDLES WERE MISSING FROM SYRINGES. VERBATIM: CONSUMER REPORTED THAT THE NEEDLE SHIELD IS DIFFICULT TO REMOVE. ALSO REPORTED NEEDLE MISSING FROM SYRINGES, STATED THAT THE NEEDLE HUB IS INTACT. LOT #: 0132212, CATALOG #: 328521, DATE OF EVENT: UNKNOWN, SAMPLES: DISCARDED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121204 SYRINGE 0.3ML 31G 6MM S/C U-100 RELION HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL - DIABETES CARE 328521 0132212 00681131138383

    Patients

    Seq Age Sex Outcome Treatment
    1