BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE TIP CAP BULK STERILE CONVENIENCE PAK

    MDR report key: 12439713 · Received September 8, 2021

    Report

    Report Number
    1213809-2021-00622
    Event Type
    Malfunction
    Date Received
    September 8, 2021
    Date of Event
    August 10, 2021
    Report Date
    August 25, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    KYW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: TWO SEALED TIP CAP TRAYS FROM BATCH #1082831 WERE RECEIVED. THE SAMPLES WERE VISUALLY EVALUATED. OF THE ONE HUNDRED TIP CAPS PRESENT BETWEEN BOTH TRAYS TWO WERE OBSERVED TO HAVE EMBEDDED FOREIGN MATTER. THE EMBEDDED FOREIGN MATTER APPEARED TO BE DEGRADED PLASTIC WHICH WAS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE EMBEDDED FOREIGN MATTER DEFECT 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. THESE CONDITIONS ARE OCCURRING AT/BELOW THEIR EXPECTED FREQUENCY. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. BATCH #1082831 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE BD¿ SYRINGE TIP CAP BULK STERILE CONVENIENCE PAK THERE WAS FOREIGN MATTER ON DEVICE CANNULA/NEEDLE/SYRINGE OR ANY FLUID PATH COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THERE IS FOREIGN MATERIAL ON THE CAP TIP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1335248 BD SYRINGE TIP CAP BULK STERILE CONVENIENCE PAK LIQUID MEDICATION DISPENSER KYW BECTON DICKINSON MEDICAL SYSTEMS 1082831

    Patients

    Seq Age Sex Outcome Treatment
    1