BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 31GA 8MM UFII 10BAG 500CS

    MDR report key: 8373788 · Received February 27, 2019

    Report

    Report Number
    1920898-2019-00209
    Event Type
    Malfunction
    Date Received
    February 27, 2019
    Date of Event
    February 6, 2019
    Report Date
    March 8, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K170386
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (5) 8MM, 31G 1.0ML BD SYRINGES AND (7) 12.7MM, 30G 1.0ML BD SYRINGES WITHOUT PACKAGING (USED). CONSUMER REPORTED SYRINGE NEEDLE NOT DRAWING INSULIN AND PLUNGER ROD DIFFICULT TO MOVE, DOES NOT RE-USE. ALL RETURNED SYRINGES WERE EXAMINED, AND A FLOW TEST WAS PERFORMED ON ALL 12. ALL 12 RETURNED SYRINGES PASSED THE FLOW TEST. THE ALLEGED DEFECTS COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 7142920. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200700956] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURES (DIFFICULT/UNABLE TO DRAW INSULIN & DIFFICULT/UNABLE TO MOVE PLUNGER ROD). COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 1.0ML 31GA 8MM UFII 10BAG 500CS EXPERIENCED DIFFICULT PLUNGER ROD MOVEMENT DURING USE AND WAS UNABLE TO DISPENSE MEDICATION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE 1.0ML 31GA 8MM UFII 10BAG 500CS EXPERIENCED DIFFICULT PLUNGER ROD MOVEMENT DURING USE AND WAS UNABLE TO DISPENSE MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166383 SYRINGE 1.0ML 31GA 8MM UFII 10BAG 500CS PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 7142910

    Patients

    Seq Age Sex Outcome Treatment
    1 Other