BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN CHRONIC CATHETER

    MDR report key: 7853169 · Received September 6, 2018

    Report

    Report Number
    3006260740-2018-02374
    Event Type
    Malfunction
    Date Received
    September 6, 2018
    Date of Event
    July 19, 2018
    Report Date
    February 28, 2019
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING REVIEW: A COMPLETE MANUFACTURING REVIEW COULD NOT BE PERFORMED, AS THE LOT NUMBER IS UNKNOWN. INVESTIGATION SUMMARY: ONE PARTIAL REPAIR SEGMENT FOR A BROVIAC CATHETER WAS RETURNED FOR EVALUATION WITH ANOTHER REPAIR SEGMENT BELONGING TO COMPLAINT 1220074 AND A FRAGMENT OF ORIGINAL CATHETER CAPTURED IN COMPLAINT 1220068. NO DAMAGE WAS VISIBLE ON THE REPAIR SEGMENT ASSOCIATED WITH THIS COMPLAINT. HOWEVER, AS ONLY A SMALL SEGMENT OF THE REPAIR KIT WAS RETURNED THE INVESTIGATION WILL REMAIN INCONCLUSIVE FOR THE ALLEGED BREAK. THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON THE AVAILABLE INFORMATION. IT IS UNKNOWN IF PATIENT AND/OR PROCEDURAL ISSUES CONTRIBUTED TO THE REPORTED EVENT. LABELING REVIEW: THE INSTRUCTIONS FOR USE (IFU) PK0713603 REV 2 THAT WAS INCLUDED WITH THE PRODUCT PRESCRIBES THE PROPER METHOD OF IMPLANTATION FOR THIS DEVICE TO PREVENT UNDUE INJURY TO THE PATIENT AND DAMAGE TO THE PRODUCT. ON SITE CARE INSTRUCTIONS STATES TO USE ALCOHOL WIPES DURING CLEANING'S. THIS IFU WARNS: DO NOT USE THE CATHETER IF THERE IS ANY EVIDENCE OF MECHANICAL DAMAGE OR LEAKING. ACCESSORIES AND USED IN CONJUNCTION WITH THIS DEVICE SHOULD INCORPORATE LUER LOCK CONNECTORS. AVOID ACCIDENTAL DEVICE CONTACT WITH SHARP INSTRUMENTS AND MECHANICAL DAMAGE TO THE CATHETER MATERIAL. USE ONLY SMOOTH EDGE ATRAUMATIC CLAMPS OR FORCEPS. AVOID PERFORATING, TEARING OR FRACTURING THE CATHETER WHEN USING A GUIDEWIRE. PRIOR TO BEGINNING PLACEMENT PROCEDURE, DO THE FOLLOWING: EXAMINE PACKAGE CAREFULLY BEFORE OPENING TO CONFIRM ITS INTEGRITY AND THAT THE EXPIRATION DATE HAS NOT PASSED. THE DEVICE IS SUPPLIED IN A DOUBLE STERILE PACKAGE AND IS NON-PYROGENIC. DO NOT USE IF PACKAGE IS DAMAGED, OPENED OR THE EXPIRATION DATE HAS PASSED. (PRODUCT IS) STERILIZED BY ETHYLENE OXIDE. DO NOT RESTERILIZE. INSPECT KIT FOR INCLUSION OF ALL COMPONENTS. DO NOT USE THE CATHETER IF THERE IS ANY EVIDENCE OF MECHANICAL DAMAGE OR LEAKING. AVOID SHARP OR ACUTE ANGLES DURING IMPLANTATION WHICH COULD COMPROMISE THE PATENCY OF THE CATHETER LUMENS. IF SUTURES ARE USED TO SECURE THE CATHETER, MAKE SURE THEY DO NOT OCCLUDE OR CUT THE CATHETER. THE CATHETER IS PLACED INTO ONE OF THE LARGE CENTRAL VEINS SO THE TIP LIES IN THE SUPERIOR VENA CAVA ABOVE THE RIGHT ATRIUM. IT IS TUNNELED SUBCUTANEOUSLY TO THE DESIRED EXIT SITE. THE SURECUFF* TISSUE INGROWTH CUFF, ATTACHED TO THE CATHETER, IS POSITIONED 3-5 CMS BELOW THE SKIN EXIT SITE IN THE TUNNEL. THE CUFF PROMOTES TISSUE INGROWTH TO SECURE THE CATHETER IN PLACE. H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CATHETER ALLEGEDLY BROKE AND WAS REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.

    Additional Manufacturer Narrative · 1

    NO MEDICAL RECORDS OR MEDICAL IMAGES HAVE BEEN MADE AVAILABLE TO THE MANUFACTURER. AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER ALLEGEDLY BROKE AND WAS REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691187 UNKNOWN CHRONIC CATHETER CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS BARD ACCESS SYSTEMS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 455 DA