BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL PRECISE

    MDR report key: 10010492 · Received April 29, 2020

    Report

    Report Number
    8041187-2020-00228
    Event Type
    Malfunction
    Date Received
    April 29, 2020
    Date of Event
    April 7, 2020
    Report Date
    June 9, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10 DEVICE AVAILABLE FOR EVAL YES, RETURNED TO MANUFACTURER ON: 2020-05-27. H.6. INVESTIGATION SUMMARY ONE PHOTO AND ONE SAMPLE WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. UPON VISUAL INSPECTION IT WAS OBSERVED THAT THE TIP HAS A SLANT; THEREFORE, THE INCIDENT COULD BE VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBERS WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. AN INVESTIGATION WAS INITIATED BY CONDUCTING A REVIEW OF THE BATCH RECORD FOR AFFECTED BATCH. THE REVIEW WAS FOCUSED ON THE MOLDING OPERATION AND ASSEMBLY OPERATION. THERE IS AN OVERHEAD CONVEYOR TRANSFER MOLDED BARREL FROM MOLDING OPERATION TO ASSEMBLY OPERATION. DURING THE TRANSFER, THE PRODUCT COULD HAVE GOTTEN STUCK FROM THE OVERHEAD CONVEYOR GAP RESULTING IN PRESSING AGAINST THE BARREL TIP CAUSING THE OBSERVED SLANT. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 50ML LL PRECISE HAD A BENT TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NOZZLE SLANTED".

    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 WAS REPORTED THAT SYRINGE 50ML LL PRECISE HAD A BENT TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NOZZLE SLANTED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476194 SYRINGE 50ML LL PRECISE SYRINGE FMF BECTON DICKINSON MEDICAL (SINGAPORE) 9353749

    Patients

    Seq Age Sex Outcome Treatment
    1 Other