BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RELION® INSULIN SYRINGE 1 ML, 31 G X 8 MM

    MDR report key: 6850646 · Received September 7, 2017

    Report

    Report Number
    1920898-2017-00160
    Event Type
    Malfunction
    Date Received
    September 7, 2017
    Date of Event
    August 15, 2017
    Report Date
    October 6, 2017
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: A SAMPLE OR PHOTO WAS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. DEVICE HISTORY RECORD REVIEW ¿ A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 7023647. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) DEFECTS OR NOTIFICATIONS NOTED FOR ANY RELATED DEFECTS DURING THE PRODUCTION OF THESE BATCHES. CONCLUSION: BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE BECAUSE NO SAMPLES OR PHOTOS WERE RECEIVED TO CONFIRM THE STATED DEFECT. IN THE EVENT THAT NEW, CHANGED, OR CORRECTED INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE FILED. IN THE EVENT THAT NEW, CHANGED, OR CORRECTED INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: N/A. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLES FROM A BD RELION® INSULIN SYRINGE 1 ML, 31 G X 8 MM BROKE OFF IN THE VIAL DURING USE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630477 BD RELION® INSULIN SYRINGE 1 ML, 31 G X 8 MM INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 7023647

    Patients

    Seq Age Sex Outcome Treatment
    1 Other