BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 29GA 12.7MM

    MDR report key: 10003444 · Received April 27, 2020

    Report

    Report Number
    1920898-2020-00430
    Event Type
    Malfunction
    Date Received
    April 27, 2020
    Date of Event
    April 7, 2020
    Report Date
    May 8, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311649
    PMA / PMN Number
    K941657
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED AS OF 7 MAY 2020 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. UNABLE TO PERFORM A DHR REVIEW DUE TO AN UNKNOWN LOT NUMBER. INVESTIGATION CONCLUSION: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. 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. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO SYRINGES 0.5ML 29GA 12.7MM EXPERIENCED MOLDING DEFECTS -SHARP PROTRUSIONS. PRODUCT DEFECT WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328507, BATCH NO: UNKNOWN (PROVIDED 4160830). CONSUMER REPORTED, HE'S CUTTING HIS FINGER ON FLANGES LOCATED ON PLUNGER ROD. STATED, FLANGES ARE REALLY SHARP DID NOT SEEK MEDICAL, ADMINISTERED HIS OWN FIRST AID AT HOME STATED, IT'S HAPPENED TWICE LOT: 4160830, CATALOG: 328507, DATE OF EVENT: UNKNOWN, SAMPLES AVAILABLE CL.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO SYRINGES 0.5ML 29GA 12.7MM EXPERIENCED MOLDING DEFECTS -SHARP PROTRUSIONS. PRODUCT DEFECT WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328507 BATCH NO: UNKNOWN (PROVIDED 4160830). CONSUMER REPORTED, HE'S CUTTING HIS FINGER ON FLANGES LOCATED ON PLUNGER ROD. STATED, FLANGES ARE REALLY SHARP DID NOT SEEK MEDICAL, ADMINISTERED HIS OWN FIRST AID AT HOME STATED, IT'S HAPPENED TWICE. LOT: 4160830, CATALOG: 328507, DATE OF EVENT: UNKNOWN, SAMPLES AVAILABLE CL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467122 SYRINGE 0.5ML 29GA 12.7MM PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328507 UNKNOWN 00681131311649

    Patients

    Seq Age Sex Outcome Treatment
    1 Other