BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH¿ IV CATHETER

    MDR report key: 8832194 · Received July 26, 2019

    Report

    Report Number
    9610048-2019-00242
    Event Type
    Malfunction
    Date Received
    July 26, 2019
    Date of Event
    July 10, 2019
    Report Date
    August 21, 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
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE UNUSED UNIT AND AN OPENED EMPTY PACKAGE AND ONE UNUSED UNIT IN A SEALED PACKAGE FROM CATALOG NUMBER 381112, LOT NUMBER 8003940. ACCORDING TO VISUAL ANALYSIS OF THE SAMPLE, THE CUSTOMER-REPORTED FOREIGN MATTER 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. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT. CONCLUSION(S): 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. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE FOREIGN MATTER WAS ON THE CATHETER WITH A BD ANGIOCATH¿ IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT SEVERAL CATHETERS HAVE A DUSTY FILM OVER THEM WHEN OPENED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 PRIOR TO USE FOREIGN MATTER WAS ON THE CATHETER WITH A BD ANGIOCATH¿ IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT SEVERAL CATHETERS HAVE A DUSTY FILM OVER THEM WHEN OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624087 BD ANGIOCATH¿ IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 8003940 30382903811121

    Patients

    Seq Age Sex Outcome Treatment
    1 Other