BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION¿ INSULIN SYRINGE

    MDR report key: 7060088 · Received November 27, 2017

    Report

    Report Number
    1920898-2017-00335
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    October 30, 2017
    Report Date
    December 28, 2017
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311762
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: CUSTOMER RETURNED (8) 1/2CC, 8MM, 31G RELION SYRINGES IN AN OPEN POLY BAG FROM LOT # 7072969. CUSTOMER STATES THAT THE SCALE MEASUREMENTS ARE BELOW THE LEVEL OF THE ZERO SYRINGE. ALL RETURNED SYRINGES WERE TESTED USING THE PLUG GAUGE AND ALL SCALE MARKING PLACEMENTS FELL WITHIN SPECIFICATIONS. AS PER MANUFACTURING, A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7072969. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200689821] NOTED FOR A PRINT DEFECT. THERE WAS ONE (1) NOTIFICATION [200689010] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A RELION¿ INSULIN SYRINGE HAS INCORRECT SCALE MARKINGS. THIS WAS DISCOVERED BEFORE USE AND THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838945 RELION¿ INSULIN SYRINGE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 7072969 00681131311762

    Patients

    Seq Age Sex Outcome Treatment
    1 Other