BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FASHIL¿ EXTENSION TUBE C35

    MDR report key: 8691789 · Received June 12, 2019

    Report

    Report Number
    2243072-2019-01153
    Event Type
    Malfunction
    Date Received
    June 12, 2019
    Date of Event
    May 28, 2019
    Report Date
    May 31, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. (B)(6). DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: WHEN WE CHECKED THE ACTUAL PRODUCT WE RECEIVED, THE TUBE WAS FOUND TO BE DAMAGED. THE RUPTURED PART WAS PRESUMED TO HAVE RUPTURED BECAUSE IT WAS SWOLLEN AND ITS THICKNESS WAS THIN. IN ADDITION, THIS PRODUCT IS SUBJECTED TO 100% APPEARANCE INSPECTION IMMEDIATELY BEFORE BEING PUT INTO INDIVIDUAL PACKAGING, AND SHIPPING TEST IN ALL PRODUCTION LOTS IN THE PAST (THE RELEVANT JIS AIR TIGHTNESS STANDARD: 150 KPA, THERE IS NO WATER LEAKAGE BY PRESSURIZATION FOR 15 MINUTES) AND, SAID JIS TENSILE STRENGTH STANDARD: WHEN NOT APPLYING A FORCE OF 15 N OR MORE FOR 15 SECONDS OR MORE, NO ABNORMALITY WAS RECOGNIZED. IN THIS EVENT, IT IS CONSIDERED THAT THE INTERNAL PRESSURE OF THE TUBE WAS EXCESSIVE AND RUPTURE OCCURRED DUE TO THE CONDITION OF THE DAMAGED PART. AS DESCRIBED IN THE PACKAGE INSERT, THERE IS A RISK OF BREAKAGE OR CRACKING DEPENDING ON THE HANDLING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD FASHIL¿ EXTENSION TUBE C35 WAS TORN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN FLOWED THE CONTRAST MEDIUM WITH 140PSI, THE EX-TUBE WAS TORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484845 BD FASHIL¿ EXTENSION TUBE C35 TUBING SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other