BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ INSULIN SYRINGE

    MDR report key: 7143994 · Received December 22, 2017

    Report

    Report Number
    1920898-2017-00405
    Event Type
    Malfunction
    Date Received
    December 22, 2017
    Date of Event
    December 5, 2017
    Report Date
    February 27, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00311917048130
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    ONE (1) 1CC, 8MM, 31G WALGREENS SYRINGE IN AN OPEN POLY BAG WAS RETURNED FROM LOT # 7121837. THE RETURNED SYRINGE WAS TESTED AND WAS NOT ABLE TO DRAW PROPERLY. THE SAMPLE WAS EXAMINED UNDER THE MICROSCOPE AND EXHIBITED ADHESIVE RUNOFF ONTO THE HUB. IT APPEARS THERE IS LITTLE ADHESIVE IN THE HUB OF THE SYRINGE. CAPA (B)(4) WAS INITIATED BY THE (B)(4) PLANT TO ADDRESS ADHESIVE RUN OVER. CAPA (B)(4) WAS INITIATED BY THE (B)(4) PLANT TO ADDRESS 1ML PRODUCT COMPLAINTS AS PER MANUFACTURING, A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7121837. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE THREE (3) NOTIFICATIONS [200697504, 200697777, 200698111] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (ADHESIVE RUNOFF) INVESTIGATION CONCLUSION: PROBABLE ROOT CAUSE DETERMINED TO BE MISALIGNMENT DURING APPLICATION OF ADHESIVE ON THE NEEDLE LINES. WHEN THIS OCCURS, ADHESIVE RUNOVER ONTO THE HUB OR POSSIBLE THE CANNULA MAY OCCUR. ADDITIONALLY, ADHESIVE MAY BE INACCURATELY APPLIED TO THE RUBBERIZED PULL WHEEL ON THE LINE, WHICH CAN ADDITIONALLY TRANSFER ADHESIVE TO THE CANNULA DURING ROUTINE USE. CAPA (B)(4) WAS INITIATED BY THE (B)(4) PLANT TO ADDRESS ADHESIVE RUNOVER. CAPA (B)(4) WAS INITIATED BY THE (B)(4) PLANT TO ADDRESS 1ML PRODUCT COMPLAINTS.

    Additional Manufacturer Narrative · 1

    IT WAS PREVIOUSLY REPORTED TO REFER TO CAPA (B)(4) FOR COMPLETE INVESTIGATION RESULTS AND ACTION PLANS. HOWEVER, CAPA (B)(4) IS NOT APPLICABLE TO THIS PRODUCT ISSUE.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE, A BD SAFETY GLIDE" INSULIN SYRINGE WAS FOUND LEAKING FROM THE CONNECTION SITE OF THE NEEDLE AND THE HUB OF THE SYRINGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923698 BD SAFETYGLIDE¿ INSULIN SYRINGE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 7121837 00311917048130

    Patients

    Seq Age Sex Outcome Treatment
    1 Other