BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIODYNAMICS / BIOFLO

    MDR report key: 6893321 · Received September 26, 2017

    Report

    Report Number
    1317056-2017-00076
    Event Type
    Injury
    Date Received
    September 26, 2017
    Date of Event
    August 22, 2017
    Report Date
    December 13, 2017
    Manufacturer
    ANGIODYNAMICS
    Product Code
    LJS
    UDI-DI
    H965458890
    PMA / PMN Number
    K121089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE OCTOBER 2017 ANGIODYNAMICS COMPLAINT REPORT WAS REVIEWED FOR THE BIOFLO PICC PRODUCT FAMILY AND THE FAILURE MODES "SHEATH LOCKING HUB ISSUE" AND "PATIENT INJURY - HEMATOMA." NO ADVERSE TRENDS WERE INDICATED. NO SAMPLE WAS RETURNED FOR EVALUATION. THE INTRODUCER COMPONENT IS SUPPLIED TO ANGIODYNAMICS BY THE SUPPLIER GALT MEDICAL. A SUPPLIER CORRECTIVE ACTION RESPONSE (SCAR) WAS ISSUED TO THE SUPPLIER, (B)(4) FOR DHR REVIEW OF SUPPLIER LOT AND NOTIFICATION OF THE EVENT. GALT MEDICAL COULD NOT INVESTIGATE THE ISSUE WITHOUT A SAMPLE, HOWEVER INDICATED THAT A POSSIBLE ROOT CAUSE FOR THESE OCCURRENCES MIGHT BE BECAUSE OF THE TIP OF THE TEARAWAY SHEATH WAS INSERTED WITHOUT DILATOR TUBE SUPPORT DUE TO LOCKING BALL DAMAGE OR THE WRONG INSERTION TECHNIQUE BY END USER. A PROCESS CAPA HAS BEEN INITIATED BY GALT TO DETERMINE IF THERE ARE ANY POTENTIAL IMPROVEMENTS TO THE MANUFACTURING PROCESS OR DESIGN FOR THE DILATOR OR TEARAWAY SHEATH TO PREVENT FUTURE OCCURRENCE TO LOCKING BALL ISSUE OF THE SHEATH/DILATOR ASSEMBLY. PR (B)(4).

    Additional Manufacturer Narrative · 1

    ALTHOUGH A SAMPLE IS NOT EXPECTED TO BE RETURNED, THE INVESTIGATION INTO THIS REPORTED EVENT IS ON-GOING. THE SHEATH/DILATOR IS A PURCHASED DEVICE FOR ANGIODYNAMICS, AND OUR SUPPLIER, GALT MEDICAL, WILL BE NOTIFIED VIA A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR). A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. (B)(4)).

    Description of Event or Problem · 1

    AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(6), "THE PEEL-APART SHEATH AND DILATOR (PACKAGED WITH THE BIOFLO PICC) WILL NOT LOCK TOGETHER RESULTING IN SEPARATION ON INSERTION TO THE VESSEL AND...ON ONE OCCASION A HAEMATOMA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674156 ANGIODYNAMICS / BIOFLO PERIPHERALLY INSERTED CENTRAL CATHETER LJS ANGIODYNAMICS 5158457 H965458890

    Patients

    Seq Age Sex Outcome Treatment
    1 Other