BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE CONTROL 10ML LL

    MDR report key: 10714926 · Received October 21, 2020

    Report

    Report Number
    1213809-2020-00730
    Event Type
    Malfunction
    Date Received
    October 21, 2020
    Date of Event
    September 28, 2020
    Report Date
    October 5, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096955
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(4). INVESTIGATION SUMMARY: NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THIS INCIDENT CANNOT BE DETERMINED. INVESTIGATION CONCLUSION: NO PHOTOS OR SAMPLES WERE RECEIVED FOR EVALUATION. ROOT CAUSE DESCRIPTION: SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED. RATIONALE: SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED CORRECTIVE ACTIONS ARE NOT NECESSARY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 SYRINGE CONTROL 10ML LL EXPERIENCED DEVICE DAMAGE/DEFORMATION WITH THE DEVICE STILL CONSIDERED OPERABLE. PRODUCT DEFECT WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309695, BATCH NO: 0113359. INJURIES OR ADVERSE EVENT: NO. LOT NUMBER: 0113359. REPORTED ISSUE: TWO EACH OF THESE BROKE DURING A HAND CASE, THE TWO RINGS THAT YOUR FINGERS GO THROUGH BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180620 SYRINGE CONTROL 10ML LL PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309695 0113359 30382903096955

    Patients

    Seq Age Sex Outcome Treatment
    1