BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC CONN TBE 7MMX3.7M BULK

    MDR report key: 6328928 · Received February 14, 2017

    Report

    Report Number
    9612030-2017-00067
    Event Type
    Malfunction
    Date Received
    February 14, 2017
    Report Date
    January 8, 2018
    Manufacturer
    COVIDIEN
    Product Code
    JOL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY; UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 1

    ONE DECONTAMINATED SAMPLE OUTSIDE OF THE ORIGINAL PACKAGE WAS RECEIVED FOR EVALUATION. THE SAMPLE WAS LABELED WITH MULTIPLE CUSTOMER COMPLAINTS: THE PHYSICAL SAMPLE RECEIVED CORRESPONDS TO PRODUCT 5558301726. AFTER PERFORMING A FUNCTIONAL INSPECTION ACCORDING TO PRODUCT SPECIFICATIONS, NO ISSUES WERE FOUND ON THE TUBE; ADDITIONALLY DIMENSIONAL INSPECTION DID NOT REVEALED ISSUES WITH THE INTERNAL DIAMETER, EXTERNAL DIAMETER AND WALL ACCORDING TO THE DRAWING SPECIFICATION. NO ISSUE WAS OBSERVED ON THE PHYSICAL SAMPLE RECEIVED THEREFORE THE REPORTED CONDITION WAS NOT CONFIRMED AND A ROOT CAUSE COULD NOT BE IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE A LOT NUMBER WAS NOT PROVIDED. THE MANUFACTURING PROCESS REVIEW FOUND THAT PRODUCT WAS MANUFACTURED IN ACCORDANCE TO THE SPECIFICATIONS REQUIRED UNDER THE OFFICIAL DOCUMENTS FORMULA SHEET AND GENERAL INSPECTION STANDARDS. A PRODUCTION NOTIFICATION WAS ISSUED TO ALL PERSONNEL TO HEIGHTEN AWARENESS OF THE CONDITION REPORTED BY THE CUSTOMER. NO CORRECTIVE ACTIONS ARE DEEMED NECESSARY AT THIS TIME BASED ON THE FINDINGS THAT THE REPORTED CONDITION COULD NOT BE CONFIRMED. WE WILL CONTINUE TO MONITOR THE PROCESS FOR ANY ADVERSE TRENDS THAT REQUIRE IMMEDIATE ATTENTION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2017 THAT A CUSTOMER HAD AN ISSUE WITH A SUCTION TUBE. THE CUSTOMER REPORTS SUCTION IN THEIR ORTHO PACKS HAS A BLUE END, IS VERY PLIABLE/RIGID RESULTING IN COLLAPSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113520 NC CONN TBE 7MMX3.7M BULK SUCTION TUBING JOL COVIDIEN 5558301726

    Patients

    Seq Age Sex Outcome Treatment
    1