BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2 GA SHARPSTAR - TRANS. RED

    MDR report key: 8131038 · Received December 4, 2018

    Report

    Report Number
    1424643-2018-00513
    Event Type
    Malfunction
    Date Received
    December 4, 2018
    Date of Event
    December 3, 2018
    Report Date
    February 14, 2019
    Manufacturer
    COVIDIEN
    Product Code
    MMK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR LOT NO. 18D07463 INDICATED THE PRODUCT WAS RELEASED MEETING ALL QUALITY STANDARDS. ALL DHRS ARE REVIEWED FOR ACCURACY PRIOR TO PRODUCT RELEASE. IN-PROCESS PROCEDURES ARE ALSO IN PLACE TO PREVENT NONCONFORMING PRODUCT IN THE MANUFACTURING PROCESS. THIS ENSURES COMPONENTS AND FINISHED PRODUCTS MEET ALL QUALITY INSPECTION STANDARDS. THESE CONTROLS INCLUDE, BUT ARE NOT LIMITED TO: MATERIAL VERIFICATION/CERTIFICATION PROCESSES, DIMENSIONAL SPECIFICATIONS, STATISTICAL SAMPLINGS, PERIODIC AUDITS, PROCESS INSPECTIONS, MACHINE MAINTENANCE/OPERATION AND PERSONNEL TRAINING AND CERTIFICATION. NO PHYSICAL SAMPLE WAS PROVIDED. CUSTOMER RELAYED IT HAD BEEN DISCARDED. WITHOUT THE ACTUAL SAMPLE, FURTHER INVESTIGATION COULD NOT BE CONDUCTED. HOWEVER, ONE (1) PHOTOGRAPH SAMPLE WAS PROVIDED FOR EVALUATION. REVIEW OF THE PHOTOGRAPH SAMPLE RESULTED IN A CONFIRMED ANALYSIS. THE CONTAINER IS SHOWN CRACKED ON THE BOTTOM, MIDDLE FROM WHAT APPEARS TO BE IMPACT. ROOT CAUSE ANALYSIS IDENTIFIED POTENTIAL ROOT CAUSES AS: THE CONTAINER MAY HAVE CRACKED DURING SHIPPING AND HANDLING DUE TO EXTERNAL STRESS/FORCES OR THE CONTAINER CRACKED DUE TO A SHARP IMPACT PRIOR TO USE. THIS ISSUE HAS BEEN DETERMINED TO BE AN ISOLATED EVENT. INSTRUCTIONS FOR USE (IFU) STATES ¿PLEASE CHECK THAT THE CONTAINER HAS SUFFERED NO SHIPPING DAMAGE BEFORE PLACING INTO USE.¿ THE PRODUCT SHOULD BE INSPECTED PRIOR TO USE FOR ANY DAMAGE. THE REPORTED CUSTOMER COMPLAINT IS CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THEY RECEIVED A SHARPS CONTAINER THAT WAS CRACKED AT THE BOTTOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    971032 2 GA SHARPSTAR - TRANS. RED CONTAINER, SHARPS MMK COVIDIEN 8534SA 18D07463

    Patients

    Seq Age Sex Outcome Treatment
    1