BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIODYNAMICS

    MDR report key: 7677277 · Received July 11, 2018

    Report

    Report Number
    1317056-2018-00128
    Event Type
    Malfunction
    Date Received
    July 11, 2018
    Date of Event
    June 11, 2018
    Report Date
    July 11, 2018
    Manufacturer
    ANGIODYNAMICS
    Product Code
    DTZ
    UDI-DI
    H965700393031
    PMA / PMN Number
    K782095
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE REPORTED PACKAGING LOT (5324731) FOR ITEM NUMBER H965700393031 FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOT MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MAY 2018 ANGIODYNAMICS COMPLAINT REPORT WAS REVIEWED FOR THE MANIFOLDS PRODUCT FAMILY AND THE FAILURE MODE "PACKAGE - HOLE/PERFORATED. " NO ADVERSE TREND WAS INDICATED. BASED ON EXAMINATION OF THE DEVICE SAMPLE RETURNED BY THE DISTRIBUTOR, THE COMPLAINT IS CONFIRMED FOR A HOLE IN THE MYLAR SIDE OF THE POUCH. ALTHOUGH WE ARE UNABLE TO DETERMINE AN EXACT ROOT CAUSE FOR THE POUCH DAMAGE, POTENTIAL ROOT CAUSES FOR THIS INCIDENT INCLUDE THE BOTTOM OF THE MANIFOLD HANDLE CORE PRESSING OUTWARD AGAINST THE MYLAR, THIS COULD BE THE RESULT OF IMPROPER SHIPPING AND HANDLING AFTER LEAVING ANGIODYNAMICS FACILITY. THE POUCHES ARE 100% INSPECTED PER ANGIODYNAMICS' PROCEDURE DURING THE SEALING PROCESS AND THE FINAL BOX PROCESS. THIS IS THE ONLY REPORTED COMPLAINT FOR THIS FAILURE MODE IN THE PAST 15 MONTHS FOR THE MANIFOLD PRODUCT FAMILY. A REVIEW OF THE ANGIODYNAMICS PACKAGING CONFIGURATION HAS BEEN PERFORMED AND HAS DETERMINED THAT THE POUCH SIZE IS APPROPRIATE FOR THE POUCH CONTENTS AND THE NUMBER OF POUCHES PER SHIPPER BOX IS ALSO APPROPRIATE. THE DIRECTIONS FOR USE (DFU) SUPPLIED WITH THE MANIFOLDS CONTAINS THE WARNING: "CONTENTS SUPPLIED STERILE USING AN ETHYLENE OXIDE (EO) PROCESS. DO NOT USE IF STERILE BARRIER IS DAMAGED. IF DAMAGE IS FOUND, CALL YOUR ANGIODYNAMICS REPRESENTATIVE. INSPECT PRIOR TO USE TO VERIFY THAT NO DAMAGE HAS OCCURRED DURING SHIPPING." (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4), A MANIFOLD POUCH WAS NOTED TO HAVE A HOLE IN THE MYLAR PORTION, THEREBY COMPROMISING THE STERILITY. THE DEVICE WAS NOT USED ON A PATIENT, AND HAS BEEN RETURNED TO ANGIODYNAMICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522098 ANGIODYNAMICS MANIFOLD DTZ ANGIODYNAMICS 5324731 H965700393031

    Patients

    Seq Age Sex Outcome Treatment
    1