BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH¿ IV CATHETER

    MDR report key: 7130780 · Received December 19, 2017

    Report

    Report Number
    9610048-2017-00095
    Event Type
    Malfunction
    Date Received
    December 19, 2017
    Date of Event
    December 1, 2017
    Report Date
    December 29, 2017
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    30382903811374
    PMA / PMN Number
    K151698
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BD RECEIVED 42 UNUSED UNITS IN SEALED PACKAGES, THREE UNUSED UNITS IN OPENED PACKAGES AND ONE OPENED EMPTY PACKAGE FROM CATALOG NUMBER 381137, LOT NUMBER 6193418. A VISUAL ANALYSIS WAS PERFORMED ON THE SAMPLES, WHICH CONFIRMED THE PRESENCE OF SILICONE DROPLETS ON THE CATHETER. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED. BASED ON THE INVESTIGATIONS CONDUCTED FOR CLAIMS OF EXCESS SILICONE OF THE ANGIOCATH NEEDLE, IT HAS BEEN FOUND THAT THE ROOT CAUSE OF THIS ON THE CATHETER IS CAUSED BY THE EXCESSIVE AMOUNT OF SILICONE THAT IS DISPENSED DURING THE SILICONIZATION OF THE CATHETER TIP TIPPER. FOR MORE DETAILS ON ROOT CAUSE CHECK CAPA # (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER, DESCRIBED AS ¿LUBE¿, WAS ATTACHED TO 4 OF THE CATHETERS OF THE BD ANGIOCATH¿ IV CATHETER 20 G. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910249 BD ANGIOCATH¿ IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 6193418 30382903811374

    Patients

    Seq Age Sex Outcome Treatment
    1 Other