BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIODYNAMICS / BIOFLO

    MDR report key: 5708820 · Received June 9, 2016

    Report

    Report Number
    1317056-2016-00079
    Event Type
    Malfunction
    Date Received
    June 9, 2016
    Date of Event
    May 13, 2016
    Report Date
    May 13, 2016
    Manufacturer
    ANGIODYNAMICS
    Product Code
    LJS
    UDI-DI
    H965458810
    PMA / PMN Number
    K121089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN INDICATED THAT THE USED SHEATH WILL BE RETURNED TO ANGIODYNAMICS, HOWEVER IT HAS NOT YET ARRIVED. THE SHEATH IS A PURCHASED COMPONENT, SO THE SUPPLIER, (B)(4), WILL BE PROVIDED WITH A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR). UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. (B)(4). DEVICE NOT YET RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THE INITIAL EVENT DESCRIPTION, PRIOR RECEIPT OF THE DEVICE SAMPLE, STATED THAT BOTH SHEATH HANDLES DETACHED FROM THE TUBING. BASED ON A REVIEW OF THE SAMPLE, HOWEVER, ONLY ONE HANDLE HAD DETACHED FROM THE SHEATH TUBING, THEREFORE THERE WAS NO RISK OF THE SHEATH TUBING MIGRATING INTO THE VESSEL (I.E., THIS WOULD NOT BE CONSIDERED AN MDR-REPORTABLE EVENT). AS AN INITIAL MEDWATCH HAD ALREADY BEEN SUBMITTED, THIS SUPPLEMENTAL MEDWATCH WILL PROVIDE THE RESULTS OF THE DEVICE EVALUATION. 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. SIMILAR COMPLAINT TREND REVIEW. THE OCTOBER 2016 ANGIODYNAMICS COMPLAINT REPORT WAS REVIEWED FOR THE BIOFLO PICC PRODUCT FAMILY AND THE FAILURE MODE "SHEATH HANDLE DETACHED - ONE." NO ADVERSE TREND WAS IDENTIFIED. AS THE SHEATH/DILATOR IS A PURCHASED DEVICE FOR ANGIODYNAMICS, THE RETURNED SAMPLE, ALONG WITH A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS FORWARDED TO OUR SUPPLIER, (B)(4). (B)(4) DETERMINATION AS TO THE ROOT CAUSE OF THIS EVENT IS THE SHEATH HANDLE WAS NOT PROPERLY MOLDED AND CONTAINED INCOMPLETE FIN FILL. ADDITIONAL ROOT CAUSE INVESTIGATION WILL BE ADDRESSED THROUGH A CAPA AT (B)(4) MEDICAL. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4), WHILE PLACING A PICC, THE USER TRIED TO PULL THE TEAR-AWAY SHEATH AND THE WINGS BROKE OFF. THE USER WAS FORCED TO REMOVE THE SHEATH OVER THE PICC LINE. ALL OF THE SHEATH WAS REMOVED, I.E., NO PATIENT COMPLICATIONS/INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365904 ANGIODYNAMICS / BIOFLO PERIPHERALLY INSERTED CENTRAL CATHETER LJS ANGIODYNAMICS 4928850 H965458810

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR