BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 7782289 · Received August 14, 2018

    Report

    Report Number
    9610048-2018-00107
    Event Type
    Malfunction
    Date Received
    August 14, 2018
    Date of Event
    July 18, 2018
    Report Date
    September 5, 2018
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO AN IT ISSUE BEGINNING ON (B)(6) 2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURE: YES. OUR QUALITY ENGINEER WAS ABLE TO VERIFY THE REPORTED COMPLAINT PER THE RETURNED SAMPLE. IT WAS POSSIBLE TO OBSERVE THAT THE FOREIGN MATTER OF "CRYSTALLIZED RESIDUES ALONG TEFLON" IS ACTUALLY SILICONE WHICH IS APPLIED TO THE CATHETER BODY TO FACILITATE ITS SLIPPAGE DURING VENIPUNCTURE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR SUB-ASSEMBLY# 004715BJF LOT 7304579 MANUFACTURED FROM (B)(6) 2017 TO (B)(6) 2017 AT ACAM01 MACHINE USED IN CLAIMED LOT 7304584. THIS LOT HAS BEEN REVISED REGARDING TESTS TO VERIFY POSSIBLE ¿FOREIGN MATTER" TESTS, AND NO RECORDS WERE FOUND THAT COULD LEAD TO THE DEFECT CLAIMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR SUB-ASSEMBLY# (B)(4), LOT 7270722 MANUFACTURED FROM 18-OCT-17 TO 01-NOV-17 AT ACAM01 MACHINE USED IN CLAIMED LOT 7304584. THIS LOT HAS BEEN REVISED REGARDING TESTS TO VERIFY POSSIBLE ¿FOREIGN MATTER" TESTS, AND NO RECORDS WERE FOUND THAT COULD LEAD TO THE DEFECT CLAIMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR SUB-ASSEMBLY# (B)(4), LOT 7241713 MANUFACTURED FROM 31-AUG-17 TO 05-SEP-17 AT ACAM01 MACHINE USED IN CLAIMED LOT 7304584. THIS LOT HAS BEEN REVISED REGARDING TESTS TO VERIFY POSSIBLE ¿FOREIGN MATTER" TESTS, AND NO RECORDS WERE FOUND THAT COULD LEAD TO THE DEFECT CLAIMED. THE ROOT CAUSE WAS DETERMINED TO BE THE EXCESSIVE AMOUNT OF SILICONE THAT IS DISPENSED DURING THE CATHETER SILICONIZATION PROCESS. A CORRECTIVE ACTION PROJECT (B)(4) HAS BEEN INITIATED TO INVESTIGATE THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD ANGIOCATH AUTOGUARD SHIELDED IV CATHETER, CRYSTALLIZED RESIDUES ARE OBSERVED THROUGHOUT TEFLON. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 BEFORE USE OF THE BD ANGIOCATH¿ AUTOGUARD¿ SHIELDED IV CATHETER, CRYSTALLIZED RESIDUES ARE OBSERVED THROUGHOUT TEFLON. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621062 BD ANGIOCATH¿ AUTOGUARD¿ SHIELDED IV CATHETER CATHETER SOLUTIONS FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 7304584

    Patients

    Seq Age Sex Outcome Treatment
    1 Other