BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 0.5ML 29GA 12.7MM BLISTER 200BX

    MDR report key: 8473773 · Received April 2, 2019

    Report

    Report Number
    1920898-2019-00304
    Event Type
    Malfunction
    Date Received
    April 2, 2019
    Date of Event
    February 11, 2019
    Report Date
    March 14, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF A BD SYRINGE. CUSTOMER STATES THAT A PART OF THE SYRINGE IS BROKEN. THE PHOTOS WERE EXAMINED AND EXHIBITED A PIECE OF THE BARREL BROKEN OFF RANGING FROM THE 0-15 UNIT MARKINGS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7240991. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE THREE (3) NOTIFICATIONS NOTED FOR DAMAGED BARREL. THERE WERE TWO (2) NOTIFICATIONS NOTED FOR DAMAGED TIPS. THERE WERE TEN (10) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. INVESTIGATION CONCLUSION: BD WAS 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: PROBABLE ROOT CAUSE WAS NOTED TO BE THE BARREL LIKELY BEING BROKEN IN THE PREP DIAL PRIOR TO ASSEMBLY, WHICH ACCOUNTS FOR THE LACK OF DAMAGE TO THE NEEDLE ASSEMBLY. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE BD SYRINGE 0.5ML 29GA 12.7MM BLISTER 200BX THE SIDE WALL OF THE CYLINDER SYRINGE IS NOT COMPLETE / A PART OF IT IS BROKEN. WHEN UNPACKING, THIS DEFECT WAS DISCOVERED BY THE NURSE. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM TO (B)(6) TO ENGLISH: DEFECTIVE INSULIN SYRINGES. THE SIDE WALL OF THE CYLINDER SYRINGE IS NOT COMPLETE / A PART OF IT IS BROKEN. WHEN UNPACKING, THIS DECEKT WAS DISCOVERED BY THE NURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265185 BD SYRINGE 0.5ML 29GA 12.7MM BLISTER 200BX INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 7240991

    Patients

    Seq Age Sex Outcome Treatment
    1 Other