BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ SYRINGES

    MDR report key: 7060400 · Received November 27, 2017

    Report

    Report Number
    1920898-2017-00348
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    November 6, 2017
    Report Date
    December 19, 2017
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903059041
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. INITIAL REPORTER ZIP:(B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: DEFECT: FM, CAT. #: 324919, BATCH#: 6055846, PRODUCT DESCRIPTION: SYRINGE 0.3ML 31GA 6MM HALF UNIT 10BAG CA, DATE(S) OF PACKAGING: 25MAR2016 TO 26MAR2016, MACHINES PACKAGED ON: (B)(4). DEVICE HISTORY RECORD REVIEW ¿ A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 6055846. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. SYRINGE ASSEMBLY ¿ THERE ONE (1) BATCH OF MATERIAL # 700003988 (SYRINGE 0.3ML ASM 31GA 6MM TW SM700176) THAT WENT INTO THE FINISHED BATCH# 6055846. BATCH# 6082682, DATES OF MANUFACTURE: 25MAR2016 TO 26MAR2016, MACHINES MANUFACTURED ON: (B)(4). THERE WERE ZERO (0) DEFECTS OR NOTIFICATIONS NOTED DURING THE PRODUCTION OF THE ABOVE LISTED BATCH. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CONSUMER WENT THROUGH FOUR BAGS AND NOTICED SYRINGES HAD FOREIGN LIQUID COME OUT OF THE BD ULTRA-FINE¿ SYRINGES. FOUND BEFORE USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840826 BD ULTRA-FINE¿ SYRINGES INSULIN SYRINGE AND NEEDLE FMF BD MEDICAL - DIABETES CARE 6055846 00382903059041

    Patients

    Seq Age Sex Outcome Treatment
    1 Other