BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8883170 · Received August 12, 2019

    Report

    Report Number
    3006948883-2019-00642
    Event Type
    Malfunction
    Date Received
    August 12, 2019
    Date of Event
    July 1, 2019
    Report Date
    August 29, 2019
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    K143610
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 7234027. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. ADDITIONALLY, ALTHOUGH A SAMPLE WAS NOT PROVIDED BY YOUR FACILITY FOR EVALUATION. PREVIOUS INSTIGATIONS HAVE SHOWN THAT A LARGE BEND SUGGESTS THE ROOT CAUSE IS A LARGE FORCE WAS APPLIED TO THE PACKAGING UNIT AFTER THE DEVICE HAD LEFT THE MANUFACTURING FACILITY, MOST LIKELY DURING SHIPPING. THE SHIPPING COMPANY HAS BEEN NOTIFIED OF THE SITUATION AND BD STANDARDS AND EXPECTATIONS HAVE BEEN RECOMMUNICATED. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM AND NEEDLE WERE FOUND DAMAGED AND BENT BEFORE USE AFTER OPENING UP THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "IT'S NOTICED THAT NEEDLE BENT AFTER UNWRAPPED THE EA PACKAGE." GOOGLE TRANSLATION (B)(6)2019 , WHEN THE NURSE LEFT THE PATIENT WITH AN INTRAVENOUS PATHWAY, OPENED THE PACKAGE AND FOUND THAT A SINGLE PIECE HAD BEEN BROKEN AND THE CATHETER AND STEEL NEEDLE WERE BENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM AND NEEDLE WERE FOUND DAMAGED AND BENT BEFORE USE AFTER OPENING UP THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "IT'S NOTICED THAT NEEDLE BENT AFTER UNWRAPPED THE EA PACKAGE." (B)(6) TRANSLATION: ON (B)(6) 2019, WHEN THE NURSE LEFT THE PATIENT WITH AN INTRAVENOUS PATHWAY, OPENED THE PACKAGE AND FOUND THAT A SINGLE PIECE HAD BEEN BROKEN AND THE CATHETER AND STEEL NEEDLE WERE BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676722 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 7234027

    Patients

    Seq Age Sex Outcome Treatment
    1 Other