BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOFLO PICC WITH ENDEXO AND PASV VALVE TECHNOLOGY

    MDR report key: 10562383 · Received September 21, 2020

    Report

    Report Number
    1317056-2020-00149
    Event Type
    Malfunction
    Date Received
    September 21, 2020
    Date of Event
    August 1, 2020
    Report Date
    December 23, 2020
    Manufacturer
    ANGIODYNAMICS
    Product Code
    LJS
    UDI-DI
    H965458810
    PMA / PMN Number
    K121089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AS THE REPORTED DEFECTIVE DEVICE WAS NOT RETURNED, ANGIODYNAMICS IS UNABLE TO PERFORM A DEVICE EVALUATION. HOWEVER, THE CUSTOMER SUPPLIED PICTURES OF THE REPORTED DEFECT. THE STATLOCK COMPONENT IS PURCHASED BY ANGIODYNAMICS FROM THE SUPPLIER BARD ACCESS SYSTEMS. THE PICTURES HAVE BEEN SENT TO BARD ACCESS SYSTEMS FOR EVALUATION, ROOT CAUSE DETERMINATION AND CORRECTIVE ACTION. SCAR004213 WAS SENT TO BARD ACCESS SYSTEMS FOR A DEVICE HISTORY RECORDS (DHR) REVIEW OF SUPPLIER LOT. COMPLAINT FILE HAS BEEN CLOSED OUT DUE TO THREE GOOD FAITH EFFORT ATTEMPTS TO THE SUPPLIER, BARD ACCESS SYSTEMS FOR DHR REVIEW OF SUPPLIER LOT. THE SUPPLIER WAS NON-RESPONSIVE. THE REPORTED COMPLAINT DESCRIPTION WAS CONFIRMED BASED ON THE PHOTOGRAPH PROVIDED. HOWEVER, A ROOT CAUSE FOR THE DEFECT COULD NOT BE DETERMINED. THE REPORTED PACKAGING LOT (5589138) FOR ITEM NUMBER (B)(4) HAD PURCHASED COMPONENT ITEM NUMBER 17700006 (ANGIODYNAMICS LOT 677186 [SL# (B)(6)]) PACKAGED IN IT. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE INDICATED PACKAGING AND COMPONENT LOTS FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. 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. REFERENCE (B)(4).

    Additional Manufacturer Narrative · 1

    THE REPORTED DEFECTIVE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR A DEVICE EVALUATION. AN INVESTIGATION INTO THE ROOT CAUSE FOR PRODUCT PROBLEM IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. REFERENCE PR25163.

    Description of Event or Problem · 1

    AN ANGIODYNAMICS TERRITORY MANAGER(TM) REPORTED AN ISSUE WITH A BIOSTABLE PICC W/PASV. IT WAS REPORTED THAT THE PICC IS NORMALLY FIXATED WITH THE STATLOCK; HOWEVER, DUE TO THE ADHESIVE ON THE STATLOCK, THE PICC REQUIRED REMOVAL AND REPLACEMENT. THERE WAS NO PATIENT INJURY OR HARM DUE TO THIS EVENT. IT WAS INDICATED THE REPORTED DEVICE IS AVAILABLE FOR RETURN TO THE MANUFATURER FOR A DEVICE EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029029 BIOFLO PICC WITH ENDEXO AND PASV VALVE TECHNOLOGY PERIPHERALLY INSERTED CENTRAL CATHETER LJS ANGIODYNAMICS 45881 5589138 H965458810

    Patients

    Seq Age Sex Outcome Treatment
    1