BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAP TIP SYR LL/LS STER LF PP NAT 50/TRAY

    MDR report key: 12443359 · Received September 8, 2021

    Report

    Report Number
    1213809-2021-00623
    Event Type
    Malfunction
    Date Received
    September 8, 2021
    Date of Event
    August 11, 2021
    Report Date
    August 26, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    KYW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED AS A DEFAULT. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1022316. MEDICAL DEVICE EXPIRATION DATE: 2026-01-31. DEVICE MANUFACTURE DATE: 2021-01-22. MEDICAL DEVICE LOT #: 0239065. MEDICAL DEVICE EXPIRATION DATE: 2025-08-31. DEVICE MANUFACTURE DATE: 2020-08-26. INVESTIGATION SUMMARY: TWO PARTIALLY OPENED TIP CAP TRAYS WERE RECEIVED (P/N (B)(4)). ONE TRAY CONTAINED NINETEEN TIP CAPS FROM BATCH #1022316 AND ONE TRAY CONTAINED THIRTY-FOUR TIP CAPS FROM BATCH #0239065. THE SAMPLES WERE VISUALLY EVALUATED. ONE TIP CAP FROM BATCH #1022316 WAS OBSERVED TO HAVE A GREY EMBEDDED FOREIGN MATTER PRESENT INTERNALLY AND EXTERNALLY THROUGHOUT THE TIP CAP. ONE TIP CAP FROM BATCH #0239065 WAS OBSERVED TO HAVE A BROWN FOREIGN MATTER PRESENT INTERNALLY AND EXTERNALLY THROUGHOUT THE TIP CAP AS WELL. THE FOREIGN MATTER APPEARED TO BE DEGRADED PLASTIC FROM THE MOLDING PROCESS IN BOTH CASES AND 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. BATCHES #1022136 AND #0239065 ARE 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING CAP TIP SYR LL/LS STER LF PP NAT 50/TRAY MOLD WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED MOLD LIKE SUBSTANCE PRESENT ON CAPS THAT WERE PACKAGED IN A STERILE PACK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1340041 CAP TIP SYR LL/LS STER LF PP NAT 50/TRAY LIQUID MEDICATION DISPENSER KYW BECTON DICKINSON MEDICAL SYSTEMS SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1