BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH¿ IV CATHETER

    MDR report key: 7768408 · Received August 9, 2018

    Report

    Report Number
    9610048-2018-00105
    Event Type
    Malfunction
    Date Received
    August 9, 2018
    Date of Event
    July 19, 2018
    Report Date
    September 18, 2018
    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

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, 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. INVESTIGATION SUMMARY: RECEIVED ONE UNUSED 24 G UNIT WITHOUT A PACKAGE AND 39 UNUSED UNITS IN SEALED PACKAGES ON 8/6/2018 FROM CATALOG NUMBER 381112, LOT NUMBER 7010867 (IN (B)(4)). SENT SAMPLES TO (B)(4) FOR FTIR TESTING ON 8/7/2018. OUR QUALITY ENGINEER WAS ABLE TO VERIFY THE REPORTED COMPLAINT OF FOREIGN MATTER. THE SAMPLE WAS SENT FOR FOURIER-TRANSFORM INFRARED SPECTROSCOPY AND THE FOREIGN MATTER WAS DETERMINED TO BE COMPOSED OF CELLOPHANE THAT COMES FROM A CLEANING CLOTH THAT IS USED IN THE FINAL ASSEMBLY PRODUCT PROCESS AND SILICONE, WHICH IS A MATERIAL USED ON THE CATHETER TO AID THE SLIPPAGE OF THE CATHETER DURING THE VENIPUNCTURE. BASED ON THE INVESTIGATION IT CAN BE VERIFIED THAT A POSSIBLE DISSEMINATOR OF CELLOPHANE PARTICLES COMES FROM WIPER CLEANING CLOTH USED TO CLEAN THE ELEVATORS OF THE ANGIOCATH ASSEMBLY MACHINES, WHICH CAN LEAVE THIS KIND OF RESIDUE. AS AN ACTION FOR THIS POTENTIAL CAUSE, THE WIPER CLOTH, WHICH CAN RELEASE PARTICLES OF CELLOPHANE WAS CHANGED TO SMALL BRUSHES COMPOSED OF NYLON BRISTLES THAT DO NOT RELEASE THIS TYPE OF PARTICLE IN THE MACHINE AVOIDING THIS TYPE OF DEFECT. AFTER PREVIOUS TESTS, THIS ACTION WAS COMPLETED IN OCTOBER / 2017. THE SECONDARY ROOT CAUSE IS SILICONE VISIBLE OF ANGIOCATH THAT IS CAUSED BY THE EXCESSIVE AMOUNT OF SILICONE THAT IS DISPENSED DURING THE SILICONIZATION OF THE CATHETER TIP TIPPING AND FINAL ASSEMBLY PROCESS. FTIR ANALYSIS WAS COMPLETED ON THE PIECE OF MATERIAL SEEN ON THE SURFACE OF THE CATHETER. THE SPECTRAL ANALYSIS SHOWS THAT THIS MATERIAL IS MOST LIKELY CELLOPHANE MIXED WITH SILICONE. DHR REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR SUB-ASSEMBLY# 004712BJF LOT 6361823 MANUFACTURED FROM 30-DEC-16 TO 30-JAN-17 AT ACAM01 MACHINE USED IN CLAIMED LOT 7010867. THIS LOT WAS REVIEWED REGARDING THE TESTS OF ¿FOREIGN MATTER¿ ON THE PRODUCT AND WERE NOT EVIDENCED RECORDS THAT COULD LEAD TO CLAIMED DEFECT. QN/ NCMR REVIEW: THERE ARE NO QUALITY NOTIFICATION (QN) OR NONCONFORMITY REPORT OF "FOREIGN MATTER" THAT COULD LEAD TO THIS COMPLAINT FOR THE CLAIMED LOT AND SUB ASSEMBLED LOT. A CORRECTIVE ACTION PROJECT HAS BEEN INITIATED TO INVESTIGATE THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD ANGIOCATH¿ IV CATHETER HAD FOREIGN MATTER ON THE CATHETER. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    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 A BD ANGIOCATH¿ IV CATHETER HAD FOREIGN MATTER ON THE CATHETER. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607324 BD ANGIOCATH¿ IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 7010867 30382903811121

    Patients

    Seq Age Sex Outcome Treatment
    1 Other