BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE TIP CAP BULK STERILE CONVENIENCE PAK

    MDR report key: 11963589 · Received June 9, 2021

    Report

    Report Number
    1213809-2021-00408
    Event Type
    Malfunction
    Date Received
    June 9, 2021
    Date of Event
    April 15, 2021
    Report Date
    June 7, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    KYW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THREE PHOTOS AND THREE SEALED PACKAGED TIP CAP TRAYS WERE RECEIVED, CONFIRMED TO BE FROM BATCH #0113389 (P/N 305822). THE SAMPLES WERE VISUALLY EVALUATED. THE FOREIGN MATTER APPEARED TO BE GREY FIBERS OF UNIDENTIFIED TYPE. THE TRAYS WERE OPENED AND THE SAME FIBER FOREIGN MATTER WAS OBSERVED TO BE ON TOP OF AND INSIDE THE TIP CAPS AS WELL. THE FOREIGN MATTER WAS OBSERVED BOTH INSIDE TRAY CAVITIES AND IN THE SEALED EDGE. THE SIZE AND AMOUNT OF FOREIGN MATTER OBSERVED WAS REJECTABLE PER PRODUCT SPECIFICATION. A SAMPLE WILL BE FORWARDED FOR FOURIER-TRANSFORM INFRARED SPECTROSCOPY (FTIR) ANALYSIS TO HELP IDENTIFY THE TYPE OF FOREIGN MATTER FOUND. CURRENT PRODUCTION WAS EVALUATED. THE FILLING AND SEALING PROCESSES ARE ENCLOSED IN PLEXIGLASS AND WERE FOUND TO BE CLEAN OF FOREIGN MATTER. NO FOREIGN MATTER WAS OBSERVED INSIDE THE PLEXIGLASS AREA. SAMPLES OF FOREIGN MATTER AROUND THE MACHINE AREA WERE TAKEN FOR FOURIER-TRANSFORM INFRARED SPECTROSCOPY (FTIR) TESTING. FOURIER-TRANSFORM INFRARED SPECTROSCOPY (FTIR) ANALYSIS WAS COMPLETED ON THE DARK MATERIAL OBSERVED IN THE SEALED TRAY ALONG WITH 4 SAMPLES FROM THE MANUFACTURING LINE IN CANAAN. A SMALL PORTION OF THESE MATERIALS WAS REMOVED FROM THE SAMPLE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SHOWS THAT THE MATERIAL IN THE TRAY IS MOST LIKELY CARDBOARD OR ANOTHER SIMILAR MATERIAL AND IS SIMILAR TO SEVERAL OF THE MATERIAL FROM THE MANUFACTURING LINE. THE MACHINE WAS NOT RUNNING FOR 12 DAYS PRIOR TO THIS BATCH STARTING PRODUCTION. IT IS POSSIBLE SOME LOOSE FOREIGN MATTER ACCUMULATED IN AND AROUND THE MACHINE AREA, INCLUDING THE OBSOLETE PIECE OF EQUIPMENT, AND THEN FOUND ITS WAY INTO THE OPENED TRAYS PRIOR TO THEM BEING SEALED. POTENTIAL ROOT CAUSE FOR THE FOREIGN MATTER DEFECT: EQUIPMENT COLLECTING DUST DURING MACHINE DOWN TIME. PROCEDURE INADEQUACIES WITH RESPECT TO MACHINE CLEANING. INADEQUATE COVERS FOR THE TRAY FLOW OUTSIDE THE PLEXIGLASS ENCLOSURE. TO ADDRESS SOME OF THE PROCESS INADEQUACIES THE FOLLOWING CORRECTIVE ACTIONS WILL BE TAKEN: THE OBSOLETE PIECE OF EQUIPMENT COLLECTING FOREIGN MATTER WILL BE REMOVED FROM THE MACHINE. DUE: (B)(6) 2021. QUALITY ALERT WILL BE ISSUED FOR AWARENESS OF THIS DEFECT. DUE: (B)(6) 2021. THE EXPOSED AREAS WILL BE EVALUATED FOR COVER REDESIGN TO BETTER PROTECT PRODUCT FROM CONTAMINATION. DUE: (B)(6) 2021. PROCEDURE WILL BE UPDATED TO BETTER REFLECT MACHINE DOWNTIME AND MACHINE CLEANING PRACTICES. DUE: (B)(6) 2021. 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 FOREIGN MATTER WAS FOUND IN THE STERILE PACKAGING OF 3 BD¿ SYRINGE TIP CAP BULK STERILE CONVENIENCE PAKS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE WOULD LIKE TO REPORT WHAT APPEARS TO BE A QUALITY ISSUE WITH BD SYRINGE TIP CAPS IN OUR INVENTORY. IT APPEARS THAT THE INSIDE OF THE STERILE PACKAGING HAS SOME DEBRIS OR FIBERS THAT QUESTION THE INTEGRITY OF THIS PRODUCT FOR USE ON STERILE COMPOUNDS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863201 BD SYRINGE TIP CAP BULK STERILE CONVENIENCE PAK LIQUID MEDICATION DISPENSER KYW BECTON DICKINSON MEDICAL SYSTEMS 0113389

    Patients

    Seq Age Sex Outcome Treatment
    1