BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL PRECISE

    MDR report key: 12339297 · Received August 18, 2021

    Report

    Report Number
    8041187-2021-00741
    Event Type
    Malfunction
    Date Received
    August 18, 2021
    Date of Event
    June 22, 2021
    Report Date
    August 30, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY BD RECEIVED THE SAMPLE FROM THE CUSTOMER'S FACILITY FOR INVESTIGATION. THE SAMPLES WAS EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE OF FOREIGN MATTER WAS OBSERVED. BASED ON THE FTIR RESULTS, THE TYPE OF FOREIGN MATTER COULD NOT BE IDENTIFIED BUT IT SHOWED FEW PEAKS SIMILAR TO THAT OF SYRINGE MATERIAL, POLYPROPYLENE. PROBABLE CAUSE OF EMBEDDED FOREIGN MATTER COULD BE A RESULT OF DEGRADED POLYPROPYLENE IN AN AGING HYDRAULIC PRESS, CLEANING OF THE INJECTION SCREW OF THE MOLDING MACHINE. A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 0233477 THE BATCH WAS MANUFACTURED ON SYRINGE ASSEMBLY 50ML IN SEP-2020. NO SIMILAR DEFECT FOUND DURING IN-PROCESS INSPECTION AND QA OUTGOING INSPECTION. NO QUALITY NOTIFICATION WAS RAISED ON PAST 12 MONTHS ON SIMILAR NON-CONFORMANCE. H3 OTHER TEXT : SEE H10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 50ML LL PRECISE HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BROWN RESIDUE IN THE SYRINGE.

    Additional Manufacturer Narrative · 1

    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 FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BROWN RESIDUE IN THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1234381 SYRINGE 50ML LL PRECISE SYRINGE FMF BECTON DICKINSON MEDICAL (SINGAPORE) 0233477

    Patients

    Seq Age Sex Outcome Treatment
    1