BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK 3ML SYRINGE

    MDR report key: 8907942 · Received August 19, 2019

    Report

    Report Number
    1213809-2019-00843
    Event Type
    Malfunction
    Date Received
    August 19, 2019
    Date of Event
    July 22, 2019
    Report Date
    September 5, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: TWO PHOTOS WERE RECEIVED AND EVALUATED. ONE PHOTO DEPICTS A LOOSE 3ML SYRINGE IN A CUSTOMER¿S HAND AND ONE PHOTO DEPICTS A LOOSE 3ML SYRINGE INSIDE A BAG WITH PRODUCT, INCLUDING CLEAR TUBING AND VARIOUS CONNECTORS. BOTH SYRINGES APPEAR TO HAVE SMALL SPOTS OF BROWN FOREIGN MATTER IN THE LUER COLLAR AND IN THE BARREL WALL NEAR THE BOTTOM OF THE BARREL. THE FOREIGN MATTER APPEARS TO BE EMBEDDED AND APPEARS TO BE LARGER THAN LEVEL 3 IN SIZE. A PHYSICAL SAMPLE IS REQUIRED TO MAKE FINAL DETERMINATION AS TO THE TYPE OF THE FOREIGN MATTER DEPICTED IN THE PHOTOS. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THE POTENTIAL ROOT CAUSE IN RESPONSE TO THE BROWN EMBEDDED FOREIGN MATTER AS SHOWN IN THE TWO PHOTOS ABOVE IS ASSOCIATED WITH THE MOLDING PROCESS. THE EMBEDDED FOREIGN MATTER IS MOST LIKELY DEGRADED PLASTIC. THIS OCCURS WHEN THE RESIN IS EXPOSED TO PROLONGED HIGH TEMPERATURES INSIDE THE MOLDING MACHINE, SUCH AS DURING START UP. PER PROCEDURE, AFTER START UP, ALL MOLDED PARTS ARE SCRAPPED UNTIL NO DEGRADED PLASTIC IS OBSERVED. IF THIS IS NOT PERFORMED THOROUGHLY A PIECE WITH THIS CONDITION CAN GET THROUGH. THIS TYPE OF DEFECT IS CONSIDERED COSMETIC. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 8001759 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. H3 OTHER TEXT : SEE SECTION H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER OCCURRED BEFORE USE WITH A BD LUER-LOK¿ 3ML SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "ON INSPECTION PRIOR TO ASSEMBLE IT HAS BEEN FOUND THAT SYRINGES ARE BEEN REJECTED DUE TO A DIRTY BROWN SUBSTANCE."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER OCCURRED BEFORE USE WITH A BD LUER-LOK¿ 3ML SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "ON INSPECTION PRIOR TO ASSEMBLE IT HAS BEEN FOUND THAT SYRINGES ARE BEEN REJECTED DUE TO A DIRTY BROWN SUBSTANCE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698474 BD LUER-LOK 3ML SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8001759

    Patients

    Seq Age Sex Outcome Treatment
    1 Other