BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION INSULIN SYRINGE

    MDR report key: 10222391 · Received July 1, 2020

    Report

    Report Number
    1920898-2020-00785
    Event Type
    Malfunction
    Date Received
    July 1, 2020
    Date of Event
    June 12, 2020
    Report Date
    July 2, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311762
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: 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# 9210536. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200837053] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT RELION® INSULIN SYRINGE NEEDLES WERE SHORT AND WOULD NOT DRAW. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328509, BATCH NO. 9210536. IT WAS REPORTED THAT NEEDLES WERE SHORTER THAN OTHERS ALTHOUGH THE BAG AND BOX HAVE THE SAME LOT AND PRODUCT INFORMATION. ALSO REPORTED NEEDLES BENT AND TWO NEEDLES WILL NOT DRAW.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: NA. 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 RELION® INSULIN SYRINGE NEEDLES WERE SHORT AND WOULD NOT DRAW. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328509 BATCH NO. 9210536. IT WAS REPORTED THAT NEEDLES WERE SHORTER THAN OTHERS ALTHOUGH THE BAG AND BOX HAVE THE SAME LOT AND PRODUCT INFORMATION. ALSO REPORTED NEEDLES BENT AND TWO NEEDLES WILL NOT DRAW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680286 RELION INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328509 9210536 00681131311762

    Patients

    Seq Age Sex Outcome Treatment
    1 Other