BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 8MM 10BAG 500

    MDR report key: 8928238 · Received August 23, 2019

    Report

    Report Number
    1920898-2019-00867
    Event Type
    Malfunction
    Date Received
    August 23, 2019
    Date of Event
    August 8, 2019
    Report Date
    September 4, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311786
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 # 7170877 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE FIFTEEN (15) 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 0.3ML 31GA 8MM 10BAG 500 HAS BEEN FOUND WITH A SHORT CANNULA DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CONSUMER THAT THE NEEDLES ARE TOO SHORT FOR HUMALIN N VIALS. VERBATIM: RELION SYRINGE CALLER USING 3/10MLCC, 31G 8MM, LOT # 7170877 UNKNOWN OCCD DATE & EXP DATE FINDING THE NEEDLES TOO SHORT FOR HUMALIN N VIALS. UNKNOWN OCCD DATES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 0.3 ML 31GA 8 MM 10BAG 500 HAS BEEN FOUND WITH A SHORT CANNULA DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CONSUMER THAT THE NEEDLES ARE TOO SHORT FOR HUMALIN N VIALS. VERBATIM: RELION SYRINGE CALLER USING 3/10 MLCC, 31G 8 MM, LOT # 7170877 UNKNOWN OCCD DATE & EXP DATE FINDING THE NEEDLES TOO SHORT FOR HUMALIN N VIALS. UNKNOWN OCCD DATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722225 SYRINGE 0.3ML 31GA 8MM 10BAG 500 PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 7170877 00681131311786

    Patients

    Seq Age Sex Outcome Treatment
    1 Other