BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ INSULIN SYRINGE 30GX8MM

    MDR report key: 6880083 · Received September 20, 2017

    Report

    Report Number
    1920898-2017-00190
    Event Type
    Malfunction
    Date Received
    September 20, 2017
    Date of Event
    August 20, 2017
    Report Date
    November 11, 2017
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K992734
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: NO SAMPLES WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. DEVICE HISTORY RECORD REVIEW ¿ A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 6232677. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. AS PER MANUFACTURING, THERE WERE SIX (6) NOTIFICATIONS FOR A RELATED DEFECT FOUND DURING THE PRODUCTION OF THE ABOVE NOTED BATCHES. ALL AFFECTED PRODUCT WAS DISPOSITIONED, AS DEEMED APPROPRIATE, PRIOR TO CLOSURE OF THIS NOTIFICATION. THERE WERE TEN (10) NOTIFICATIONS THAT DID NOT OBTAIN TO THE DEFECT. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE BD SAFETYGLIDE¿ INSULIN SYRINGE 30GX8MM HAD BLURRED MARKINGS ON THE SCALE MAKING THE PRODUCT DEFECTIVE. FOUND BEFORE USE. NO SERIOUS INJURY OR MEDICAL INJURY NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658725 BD SAFETYGLIDE¿ INSULIN SYRINGE 30GX8MM SAFETY ENGINEERED INSULIN SYRINGE AND NEEDLE FMF BD MEDICAL - DIABETES CARE 6232677

    Patients

    Seq Age Sex Outcome Treatment
    1 Other