BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH¿ IV CATHETER

    MDR report key: 8555815 · Received April 26, 2019

    Report

    Report Number
    9610048-2019-00160
    Event Type
    Malfunction
    Date Received
    April 26, 2019
    Date of Event
    April 9, 2019
    Report Date
    June 11, 2019
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    30382903811121
    PMA / PMN Number
    K151698
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: DHR REVIEW WAS DONE AND THIS LOT WAS REVIEWED REGARDING THE TESTS OF ¿FOREIGN MATTER/ VISIBLE SILICONE¿, WERE NOT EVIDENCED RECORDS THAT COULD LEAD TO THE CLAIMED DEFECT. WAS RECEIVED ON 24-APR-2019 IN DB SANDY ONE UNUSED UNIT WITHOUT PACKAGING FROM CATALOG NUMBER 381112, LOT NUMBER 7241831. ACCORDING TO THE VISUAL ANALYSIS OF THE SAMPLE CAN OBSERVE THAT THE FOREIGN MATTER FOUND IS SILICONE. IT SHOULD BE NOTED THAT THIS SILICONE DOES NOT CAUSE HARM TO THE WEARER AND IS USED TO AID IN THE SLIPPAGE OF THE CATHETER DURING VENIPUNCTURE. BASED ON THE INVESTIGATIONS CONDUCTED FOR COMPLAINTS OF SILICONE VISIBLE OF ANGIOCATH, IT HAS BEEN FOUND THAT THE ROOT CAUSE OF THIS ISSUE ON THE CATHETER IS CAUSED BY THE EXCESSIVE AMOUNT OF SILICONE THAT IS DISPENSED DURING THE SILICONIZATION OF THE CATHETER TIP TIPPING AND FINAL ASSEMBLY PROCESS. CAPA#450094 WAS INITIATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS FOREIGN MATTER ON TIP OF NEEDLE WITH A BD ANGIOCATH¿ IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: FM IS ON THE NEEDLE TIP.

    Additional Manufacturer Narrative · 1

    (B)(6). A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS FOREIGN MATTER ON TIP OF NEEDLE WITH A BD ANGIOCATH¿ IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: FM IS ON THE NEEDLE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347491 BD ANGIOCATH¿ IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 7241831 30382903811121

    Patients

    Seq Age Sex Outcome Treatment
    1 Other