BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 31GA 8MM UFII 10BAG 500CS

    MDR report key: 8970845 · Received September 6, 2019

    Report

    Report Number
    1920898-2019-00928
    Event Type
    Malfunction
    Date Received
    September 6, 2019
    Date of Event
    August 21, 2019
    Report Date
    September 23, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908468039
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    LEVEL A INVESTIGATION - COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR NEEDLE HUB SEPARATES AND DIFFICULT/UNABLE TO OPERATE (NOT DRAWING) ON LOT # 9070560. 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# 9070560. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [(B)(4)] NOTED FOR CRACKED HUBS 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 UFII 10BAG 500CS HAS BEEN FOUND EXPERIENCING ONE OCCURRENCE OF HUB SEPARATING FROM THE DEVICE AND FOUR INSTANCES OF INABILITY TO OPERATE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT NEEDLE HUB SEPARATED FROM ONE SYRINGE AND WAS NOT ABLE TO DRAW MEDICATION ON 4 SYRINGES. VERBATIM: LOT: 9070560 ITEM: 328468 EXPIRATION DATE: 2024-03-31 INCIDENT DATES, UNKNOWN CONSUMER REPORTED: NEEDLE HUB SEPARATED ON 1 SYRINGE NOT ABLE TO DRAW INSULIN WITH 4 SYRINGES NEW TO INJECTION WITH SYRINGES. USED PEN NEEDLES FOR YEARS BUT NOW CANNOT AFFORD THEM. SAMPLES AVAILABLE THE ISSUES MENTIONED HAPPENED ON DIFFERENT DAYS. CONSUMER COULD NOT PROVIDE DATES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 0.5 ML 31GA 8 MM UFII 10BAG 500CS HAS BEEN FOUND EXPERIENCING ONE OCCURRENCE OF HUB SEPARATING FROM THE DEVICE AND FOUR INSTANCES OF INABILITY TO OPERATE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT NEEDLE HUB SEPARATED FROM ONE SYRINGE AND WAS NOT ABLE TO DRAW MEDICATION ON 4 SYRINGES. VERBATIM: LOT: 9070560. ITEM: 328468. EXPIRATION DATE: 2024-03-31. INCIDENT DATES, UNKNOWN. CONSUMER REPORTED: NEEDLE HUB SEPARATED ON 1 SYRINGE. NOT ABLE TO DRAW INSULIN WITH 4 SYRINGES. NEW TO INJECTION WITH SYRINGES. USED PEN NEEDLES FOR YEARS BUT NOW CANNOT AFFORD THEM. SAMPLES AVAILABLE. THE ISSUES MENTIONED HAPPENED ON DIFFERENT DAYS. CONSUMER COULD NOT PROVIDE DATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764893 SYRINGE 0.5ML 31GA 8MM UFII 10BAG 500CS PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 9070560 00382908468039

    Patients

    Seq Age Sex Outcome Treatment
    1 Other