BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ BULK STERILE CONVENIENCE PAK TIP CAP SYRINGE

    MDR report key: 14407521 · Received May 16, 2022

    Report

    Report Number
    1213809-2022-00286
    Event Type
    Malfunction
    Date Received
    May 16, 2022
    Date of Event
    March 1, 2022
    Report Date
    June 8, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    KYW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 27-MAY-2022. H.6. INVESTIGATION: FIFTY SAMPLE AND TWO PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, IT IS OBSERVED THAT ONE SAMPLE WITH THREE BROWNISH-BLACK AREAS WHICH IS IDENTIFIED AS EMBEDDED FOREIGN MATTER. 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. THIS TYPE OF DEFECT IS COSMETIC AND DOES NOT POSE RISK TO THE CUSTOMER. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED BATCH NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BROWN FOREIGN MATTER WAS FOUND IN THE BD¿ BULK STERILE CONVENIENCE PAK TIP CAP SYRINGES STERILE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER COMPLAINED THAT BROWNISH SPOTS WERE FOUND IN THE PRODUCT OF THE STERILE PACK."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BROWN FOREIGN MATTER WAS FOUND IN THE BD¿ BULK STERILE CONVENIENCE PAK TIP CAP SYRINGES STERILE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER COMPLAINED THAT BROWNISH SPOTS WERE FOUND IN THE PRODUCT OF THE STERILE PACK.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1745005 BD¿ BULK STERILE CONVENIENCE PAK TIP CAP SYRINGE LIQUID MEDICATION DISPENSER KYW BECTON DICKINSON MEDICAL SYSTEMS 1200274

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown