BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 5ML LUER-LOK SYRINGE

    MDR report key: 9271664 · Received November 4, 2019

    Report

    Report Number
    8041187-2019-00889
    Event Type
    Malfunction
    Date Received
    November 4, 2019
    Date of Event
    October 17, 2019
    Report Date
    December 2, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED. BASED ON THE DHR REVIEWED THERE WERE NO ABNORMALITY DURING PRODUCTION RUN. A REVIEW OF PAST YEAR SYRINGE PROCESS AND THERE WAS NO CHANGE IN MATERIAL USED IN SYRINGE. THE TEAM HAD ENGAGED R&D ON COLOR CHANGE IN TOP WEB GRAPHIC COMPLAINT. TOXICOLOGY TEST WAS PERFORMED AND MEET THE ACCEPTANCE CRITERIA. THE AFFECTED BATCH 9081759 PASSED THE BIOLOGICAL INDICATOR STERILITY TEST RESULT (BI) ACCEPTANCE CRITERIA BEFORE RELEASE. HENCE, ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD 5ML LUER-LOK¿ SYRINGE INK WAS DISCOLORED. THIS OCCURRED ON 16 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INK ON PACKAGING DISCOLORED - RED TINGED. OT REFUSING TO USE PRODUCT AS CONCERNED STERILITY IS COMPROMISED. 04NOV2019: ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER: IT WAS THE PRINT ON THE WRAPPER CONTAINING THE SYRINGE. ALL INFORMATION COULD BE READ AND NONE WAS MISSING.

    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 BD 5ML LUER-LOK¿ SYRINGE INK WAS DISCOLORED. THIS OCCURRED ON 16 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INK ON PACKAGING DISCOLORED - RED TINGED. OT REFUSING TO USE PRODUCT AS CONCERNED STERILITY IS COMPROMISED. 04NOV2019: ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER: IT WAS THE PRINT ON THE WRAPPER CONTAINING THE SYRINGE. ALL INFORMATION COULD BE READ AND NONE WAS MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1070802 BD 5ML LUER-LOK SYRINGE SYRINGE FMF BECTON DICKINSON MEDICAL (SINGAPORE) 9081759

    Patients

    Seq Age Sex Outcome Treatment
    1 Other