BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 29GA 1/2IN BLS 400 SG

    MDR report key: 9157909 · Received October 4, 2019

    Report

    Report Number
    1920898-2019-01091
    Event Type
    Malfunction
    Date Received
    October 4, 2019
    Date of Event
    September 19, 2019
    Report Date
    September 27, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    MEG
    PMA / PMN Number
    K992734
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) 1ML, 13MM, 29G BD SAFETY GLIDE INSULIN SYRINGE IN AN OPEN BLISTER PACK FROM LOT # 8002679. CUSTOMER STATES THAT THE NEEDLE ROTATED A LITTLE WHEN ROTATING THE NEEDLE PROTECTION DEVICE. THE RETURNED SYRINGE WAS TESTED AND THE CANNULA WAS NOT ABLE TO ROTATE IN THE HUB OF THE SYRINGE. THE CANNULA WAS FIRMLY HELD IN THE HUB OF THE SYRINGE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8002679. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. INVESTIGATION CONCLUSION: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE SYRINGE 1.0ML 29GA 1/2IN BLS 400 SG THE NEEDLE ROTATED WHEN ROTATING THE NEEDLE PROTECTION DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: USER COMPLAINED THAT WHEN ROTATE THE NEEDLE PROTECTION DEVICE, THE NEEDLE ROTATE A LITTLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    953193 SYRINGE 1.0ML 29GA 1/2IN BLS 400 SG SYRINGE, ANTISTICK MEG BD MEDICAL - DIABETES CARE 8002679

    Patients

    Seq Age Sex Outcome Treatment
    1 Other