BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBSTETRICAL KIT

    MDR report key: 19415615 · Received May 29, 2024

    Report

    Report Number
    1047429-2024-00002
    Event Type
    Injury
    Date Received
    May 29, 2024
    Date of Event
    May 2, 2024
    Report Date
    July 1, 2024
    Manufacturer
    AVID MEDICAL, INC.
    Product Code
    OKV
    UDI-DI
    10809160411681
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT IS NOT AVAILABLE FOR EVALUATION. AVID MEDICAL IS A CONVENIENCE KIT MANUFACTURER. THE COMPLAINT COMPONENT IS (B)(6) HOSPITAL DISPOSABLES PART NUMBER 385 (REGISTRATION NUMBER: 2433012). A SUPPLIER CORRECTIVE ACTION REQUEST WAS ISSUED TO THE COMPONENT MANUFACTURER ON (B)(6), 2024. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE FILED. THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY. H3 OTHER TEXT: DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT IS NOT AVAILABLE FOR EVALUATION. THE REPORTED COMPLAINT HAS BEEN EVALUATED AND THE INVESTIGATION PROCESS HAS BEEN COMPLETED. THE INVESTIGATION PROCESS INCLUDED A THOROUGH REVIEW OF ALL PRODUCTION AND QUALITY INSPECTION DOCUMENTS. THESE DOCUMENTS DID NOT REVEAL ANY DEVIATION FROM STANDARD PROCEDURES ESTABLISHED FOR THE PRODUCTION OF THE KIT REPORTED OR THE INSPECTION OF THE SPECIFIC PART WITH THE ISSUE. FURTHERMORE, OUR CURRENT STOCK OF UMBILICAL CORD CLAMPS WAS RE-INSPECTED AND FOUND TO BE CONFORMING. A SUBSEQUENT PRODUCTION RUN OF THE SAME PRODUCT WAS MONITORED CLOSELY, AND NO DEFECTS REPLICATING THE REPORTED ISSUE WAS IDENTIFIED. A REVIEW OF REJECTION DATA SHOWED NO FUNCTIONAL DEFECTS FOR THIS COMPONENT. THIS IS THE FIRST RELATED COMPLAINT FOR THE INSTRUMENT. DESPITE OUR INVESTIGATION NOT IDENTIFYING A CLEAR CAUSE FOR THE ISSUE AND FINDING NO DEFECTS IN THE PRODUCTS, WE BELIEVE THIS IS AN ISOLATED ISSUE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY AND QUARTERLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. A ROOT CAUSE WAS NOT DETERMINED. THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY. H3 OTHER TEXT : DEVICE NOT RETURNED

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED UMBILICAL CORD CLAMP REOPENED AFTER BEING CLAMPED. THIS RESULTED IN INFANT BLOOD LOSS. MEDICAL TREATMENT WAS ADMINISTERED TO STOP BLEEDING. THE INFANT IS IN GOOD STATUS, DISCHARGED FROM HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660241 OBSTETRICAL KIT OBSTETRICAL KIT OKV AVID MEDICAL, INC. SINA214 1597123 10809160411681

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other