BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOFLO DIALYSIS CATHETER

    MDR report key: 10148790 · Received June 12, 2020

    Report

    Report Number
    1317056-2020-00103
    Event Type
    Malfunction
    Date Received
    June 12, 2020
    Date of Event
    June 2, 2020
    Report Date
    August 18, 2020
    Manufacturer
    ANGIODYNAMICS
    Product Code
    MSD
    UDI-DI
    H965103038191
    PMA / PMN Number
    K131260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AS THE REPORTED DEVICE WAS NOT RETURNED, ANGIODYNAMICS IS UNABLE TO PERFORM A DEVICE EVALUATION. THE REPORTED COMPLAINT DESCRIPTION CANNOT BE CONFIRMED AS THERE WAS NO DEVICE TO EVALUATE. THE ROOT CAUSE FO THE REPORTED COMPLAINT CANNOT BE DETERMINED. ANGIODYNAMICS' SUPPLIER OF THIS DEVICE WAS MADE AWARE OF THE EVENT. PER THE ATTACHED SCAR004120 RESPONSE FROM MARTECH MEDICAL, NO PICTURES OR SAMPLES WERE RECEIVED BY SUPPLIER. PRODUCTION RECORDS WERE REVIEWED, QUALITY RECORDS, AND RETAINED SAMPLES FOR PRODUCTION LOT 061219-1. THE SAME GRADE OF MATERIAL AND COLORANT HAVE BEEN USED FOR THIS PART SINCE 2005. THE PART IS MOLDED WITH ALL VIRGIN MATERIAL AND THE DIMENSIONAL INSPECTIONS ARE WITHIN THE PRINT TOLERANCES. RETAINED SAMPLES FROM THIS LOT WERE PRESSED FLAT AND THEY DID NOT CRACK. THE PROCESS PARAMETERS ARE CONSISTENT AND NO CHANGES HAVE BEEN DONE TO THE MOLD. LABELING REVIEW: DIRECTIONS FOR USE IS PROVIDED WITH THIS DEVICE AND CONTAINS THE FOLLOWING STATEMENT: USE BLUNT DISSECTION TO CREATE THE SUBCUTANEOUS TUNNEL OPENING. ATTACH THE CATHETER TO THE TROCAR (A SLIGHT TWISTING MOTION MAY BE HELPFUL). SLIDE CATHETER TUNNELING SLEEVE OVER THE CATHETER MAKING CERTAIN THAT THE SLEEVE COVERS THE DISTAL TIP OF THE CATHETER. INSERT THE TROCAR INTO THE EXIT SITE AND CREATE A SHORT SUBCUTANEOUS TUNNEL. DO NOT TUNNEL THROUGH MUSCLE. THE TUNNEL SHOULD BE MADE WITH CARE IN ORDER TO PREVENT DAMAGE TO SURROUNDING VESSELS. A REVIEW OF THE ANGIODYNAMICS COMPLAINT SYSTEM NOTED NO ADVERSE TRENDS FOR THIS COMPLAINT TYPE AND PRODUCT FAMILY. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. COMPLAINT REFERENCE (B)(4).

    Additional Manufacturer Narrative · 0

    AS THE REPORTED DEVICE WAS NOT RETURNED, ANGIODYNAMICS IS UNABLE TO PERFORM A DEVICE EVALUATION. THE REPORTED COMPLAINT DESCRIPTION CANNOT BE CONFIRMED AS THERE WAS NO DEVICE TO EVALUATE. THE ROOT CAUSE FO THE REPORTED COMPLAINT CANNOT BE DETERMINED. ANGIODYNAMICS' SUPPLIER OF THIS DEVICE WAS MADE AWARE OF THE EVENT. PER THE ATTACHED SCAR004120 RESPONSE FROM MARTECH MEDICAL, NO PICTURES OR SAMPLES WERE RECEIVED BY SUPPLIER. PRODUCTION RECORDS WERE REVIEWED, QUALITY RECORDS, AND RETAINED SAMPLES FOR PRODUCTION LOT 061219-1. THE SAME GRADE OF MATERIAL AND COLORANT HAVE BEEN USED FOR THIS PART SINCE 2005. THE PART IS MOLDED WITH ALL VIRGIN MATERIAL AND THE DIMENSIONAL INSPECTIONS ARE WITHIN THE PRINT TOLERANCES. RETAINED SAMPLES FROM THIS LOT WERE PRESSED FLAT AND THEY DID NOT CRACK. THE PROCESS PARAMETERS ARE CONSISTENT AND NO CHANGES HAVE BEEN DONE TO THE MOLD. LABELING REVIEW: DIRECTIONS FOR USE IS PROVIDED WITH THIS DEVICE AND CONTAINS THE FOLLOWING STATEMENT: USE BLUNT DISSECTION TO CREATE THE SUBCUTANEOUS TUNNEL OPENING. ATTACH THE CATHETER TO THE TROCAR (A SLIGHT TWISTING MOTION MAY BE HELPFUL). SLIDE CATHETER TUNNELING SLEEVE OVER THE CATHETER MAKING CERTAIN THAT THE SLEEVE COVERS THE DISTAL TIP OF THE CATHETER. INSERT THE TROCAR INTO THE EXIT SITE AND CREATE A SHORT SUBCUTANEOUS TUNNEL. DO NOT TUNNEL THROUGH MUSCLE. THE TUNNEL SHOULD BE MADE WITH CARE IN ORDER TO PREVENT DAMAGE TO SURROUNDING VESSELS. A REVIEW OF THE ANGIODYNAMICS COMPLAINT SYSTEM NOTED NO ADVERSE TRENDS FOR THIS COMPLAINT TYPE AND PRODUCT FAMILY. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. COMPLAINT REFERENCE (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE DISPOSABLE DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. AN INVESTIGATION INTO THE ROOT CAUSE OF THIS INCIDENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. (B)(4).

    Description of Event or Problem · 1

    EVENT #2 AN IMAGING SUPERVISOR REPORTED THAT THE TUNNELER SLEEVE COMPONENT OF THIS BIOFLO CHRONIC DIALYSIS CATHETER SLID OFF THE TUNNELER AND BECOME DETACHED IN THE PATIENT WHILE TUNNELING WAS BEING PERFORMED. THE SLEEVE WAS ABLE TO BE REMOVED AFTER IT WAS NOTICED TO BE MISSING FROM THE TUNNELER. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614685 BIOFLO DIALYSIS CATHETER CATHETER, HEMODIALYSIS, IMPLANTED MSD ANGIODYNAMICS 5561864 H965103038191

    Patients

    Seq Age Sex Outcome Treatment
    1