BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 31GA 8MM 10 BAG 500

    MDR report key: 9203696 · Received October 17, 2019

    Report

    Report Number
    1920898-2019-01163
    Event Type
    Malfunction
    Date Received
    October 17, 2019
    Date of Event
    October 1, 2019
    Report Date
    November 4, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311762
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9070565. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE FOUR (4) NOTIFICATIONS [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: -UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE SYRINGE 0.5ML 31GA 8MM 10 BAG 500 HAS BEEN FOUND EXPERIENCING TWO OCCURRENCES OF MOLDING DEFECTS DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BENT BARREL. VERBATIM: ISSUE: CONSUMER REPORTED BENT BARREL. SAMPLE AVAILABLE. SHE USES THE 31 G, 1/2 ML 5/16. 8MM INCIDENT DATE: (B)(6) 2019. OCCURENCE- 2 LOT# 9070565 ITEM# 328509.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE SYRINGE 0.5ML 31GA 8MM 10 BAG 500 HAS BEEN FOUND EXPERIENCING TWO OCCURRENCES OF MOLDING DEFECTS DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BENT BARREL. VERBATIM: ISSUE: CONSUMER REPORTED BENT BARREL. SAMPLE AVAILABLE. SHE USES THE 31 G, 1/2 ML 5/16. 8MM. INCIDENT DATE: (B)(6) 2019, OCCURENCE: 2, LOT#: 9070565, ITEM#: 328509.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1000168 SYRINGE 0.5ML 31GA 8MM 10 BAG 500 PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 9070565 00681131311762

    Patients

    Seq Age Sex Outcome Treatment
    1 Other