BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRO SAFETY GWI NEEDLE

    MDR report key: 5135311 · Received October 8, 2015

    Report

    Report Number
    1060680-2015-00042
    Event Type
    Malfunction
    Date Received
    October 8, 2015
    Date of Event
    August 25, 2015
    Report Date
    October 6, 2015
    Manufacturer
    NEO MEDICAL, INC.
    Product Code
    DWS
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: 1) CALL (B)(4) WAS RECEIVED INDICATING THAT FINISHED GOOD SPG-101-21-07, (B)(4) PRO SAFETY GWI NEEDLE, HAD A BREAKAGE OCCUR RESULTING IN A NEEDLE STICK. 2) THE PRODUCT IS IDENTIFIED WITHIN THE MASTER PLANNING AS A "RELABEL" DEVICE SUPPLIED BY CA-NEO MEDICAL, INC. (B)(4) WAS ISSUED. THE QC COMPLAINT SPECIALIST FOLLOWED UP WITH THE VENDOR ON (B)(4) 2015 AS A REMINDER OF THE APPROACHING SCAR DUE DATE. CA-NEO MEDICAL, INC. SUPPLIED THE SCAR RESPONSE ON (B)(4) 2015. REFER TO THE (B)(4) CALL (B)(4) ATTACHMENT. 3)THE QC COMPLAINT SPECIALIST REVIEWED THE QFI REPORT FOR SALES AND SIMILAR COMPLAINT INFORMATION. (B)(4). NO PREVIOUS REPORTS HAVE BEEN RECEIVED FOR THE REPORTED ISSUE. 4) DEROYAL WILL CONTINUE TO MONITOR TRENDS FOR THIS FAILURE AND WILL RECOGNIZE IN THE FUTURE IF IT TRANSITIONS INTO A RECURRING ISSUE. CORRECTION: A CORRECTION HAS NOT BEEN TAKEN. ROOT CAUSE ANALYSIS: SCAR: UNKNOWN. NO PRODUCT WAS AVAILABLE FOR INSPECTION OR REVIEW. DEROYAL: THE REPORTED ISSUE HAS BEEN DETERMINED TO BE AN ISOLATED EVENT DUE TO AN UNDETERMINED TRUE ROOT CAUSE. A LOT NUMBER WAS NOT REPORTED AND A SAMPLE HAS NOT BEEN PROVIDED FOR EVALUATION. CORRECTIVE ACTION AND/OR SYSTEMIC CORRECTION ACTION TAKEN: NO ACTIONS WERE TAKEN OR REQUIRED BY OUR CAPA SYSTEM DUE TO THIS BEING THE FIRST REPORTED INCIDENT OF THIS NATURE OUT OF (B)(4) UNITS SOLD SINCE 2008. PREVENTIVE ACTION: SCAR: A PREVENTIVE ACTION HAS NOT BEEN TAKEN. INVESTIGATION IS COMPLETE AT THIS TIME. THIS REPORT WILL BE UPDATED AS MORE INFORMATION BECOMES AVAILABLE. DEVICE DISCARDED BY USER.

    Description of Event or Problem · 1

    THE NURSE USED THE NEEDLE. THEN WHEN SHE WENT TO SLIDE THE SHEATH OVER THE NEEDLE. AT THAT POINT, THE SHEATH WAS COMPLETELY EXTENDED, AND THE PLASTIC SHEATH BROKE AT THE BASE OF THE NEEDLE. THE NURSE'S HAND BOUNCED BACK AFTER THE SHEATH BROKE AND STUCK HER HAND. THE PATIENT HAD C. DIFF. THE NURSE WAS TREATED WITH PREVENTION DRUGS AND MEDICAL CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669696 PRO SAFETY GWI NEEDLE INSTRUMENTS, SURGICAL, CARDIOVASCULAR DWS NEO MEDICAL, INC. NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention