BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER TIP CAP, STERILE TRAY

    MDR report key: 8085923 · Received November 19, 2018

    Report

    Report Number
    1213809-2018-00800
    Event Type
    Malfunction
    Date Received
    November 19, 2018
    Date of Event
    November 2, 2018
    Report Date
    January 11, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    KYW
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE TRAY OF 50 CAP TIPS WAS RECEIVED, CONFIRMED TO BE FROM BATCH #5201798 (P/N 305822). THE SAMPLE WAS VISUALLY EVALUATED. ONE OF THE CAP TIPS WAS FOUND TO HAVE A SMALL BLACK PIECE OF EMBEDDED FOREIGN MATTER LARGER THAN LEVEL 3 IN SIZE. THE FOREIGN MATTER THE SIZE OBSERVED IS REJECTABLE PER PRODUCT SPECIFICATION. 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 COSMETIC AND DOES NOT POSE RISK TO THE CUSTOMER. 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 POTENTIAL ROOT CAUSE FOR THE EMBEDDED FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE MOLDING PROCESS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD LUER TIP CAP, STERILE TRAY THERE WAS AN ISSUE WITH FOREIGN MATTER. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.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 WITH THE USE OF THE BD LUER TIP CAP, STERILE TRAY THERE WAS AN ISSUE WITH FOREIGN MATTER. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922840 BD LUER TIP CAP, STERILE TRAY LIQUID MEDICATION DISPENSER KYW BECTON DICKINSON MEDICAL SYSTEMS 5201798

    Patients

    Seq Age Sex Outcome Treatment
    1 Other