BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH¿ IV CATHETER

    MDR report key: 8232406 · Received January 9, 2019

    Report

    Report Number
    9610048-2018-00222
    Event Type
    Malfunction
    Date Received
    January 9, 2019
    Date of Event
    December 18, 2018
    Report Date
    April 23, 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
    LE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION:BD WAS ABLE TO VERIFY THE REPORTED ISSUE OF FOREIGN MATTER ON THE CATHETER. WHEN THE SAMPLES ARRIVED IT APPEARED TO HAVE A STRAND ON ONE SAMPLE AND EXCESS SILICONE ON ALL OF THE SAMPLES. THE SAMPLE WERE SENT FOR FOURIER-TRANSFORM INFRARED SPECTROSCOPY WHICH VERIFIED THE CLEAR DROPLETS WERE SILICONE AN THE STRAND WAS A HAIR. IT SHOULD BE NOTED THAT THIS SILICONE DOES NOT CAUSE DAMAGE TO THE USER AND IS USED TO AID IN THE SLIPPAGE OF THE CATHETER DURING VENIPUNCTURE. 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. A CORRECTIVE ACTION PROJECT, CAPA#450094, HAS BEEN INITIATED TO INVESTIGATE THE ISSUE. FOR THE FOREIGN MATTER DEFECT (HAIR) BASED ON THE INVESTIGATION RESULTS TO DATE THE ROOT CAUSE WAS NOT DETERMINATE FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD ANGIOCATH¿ IV CATHETER THERE WAS AN ISSUE OF PARTICLES OR SMALL PIECES FROM THE CANNULA MATERIAL ON THE OUTER SURFACE OF THE CANNULA. THIS OCCURRED ONCE WITH LOT# 7172785 AND ONCE WITH LOT# 7088760.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7172785. MEDICAL DEVICE EXPIRATION DATE: 2022-05-31. DEVICE MANUFACTURE DATE: 2017-07-07. MEDICAL DEVICE LOT #: 7088760. MEDICAL DEVICE EXPIRATION DATE: 2022-03-31. DEVICE MANUFACTURE DATE: 2017-04-12. 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 WITH THE USE OF THE BD ANGIOCATH¿ IV CATHETER THERE WAS AN ISSUE OF PARTICLES OR SMALL PIECES FROM THE CANNULA MATERIAL ON THE OUTER SURFACE OF THE CANNULA. THIS OCCURRED ONCE WITH LOT# 7172785 AND ONCE WITH LOT# 7088760.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25023 BD ANGIOCATH¿ IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. SEE H.10 30382903811121

    Patients

    Seq Age Sex Outcome Treatment
    1 Other