BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UMBLICAL CORD CLAMP

    MDR report key: 20148487 · Received September 5, 2024

    Report

    Report Number
    3003753847-2024-00001
    Event Type
    Injury
    Date Received
    September 5, 2024
    Report Date
    December 12, 2024
    Manufacturer
    OWENS & MINOR DISTRIBUTION, INC.
    Product Code
    HFW
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THIS EVENT IS NOT AVAILABLE FOR EVALUATION. OWENS & MINOR DISTRIBUTION, INC. IS THE INITIAL IMPORTER AND DISTRIBUTOR OF THE MEDICAL DEVICE. THE PRODUCT IS SUPPLIED BY MAC MEDICAL SUPPLY COMPANY, INC. (FDA REGISTRATION NUMBER: 3004963952). A SCAR (SUPPLIER CORRECTIVE ACTION REQUEST) WAS ISSUED ON AUGUST 22, 2024. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). 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 HAS CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    SAMPLE WAS REVIEWED BY MANUFACTURER AND FOUND TO BE CONFORMING WITH SPECIFICATION AND PERFORM AS INTENDED. THE MANUFACTURER INDICATED IT IS POSSIBLE THAT THE END-USER MAY NOT HAVE FULLY ENGAGED THE CLAMP CAUSING IT TO NOT BE CONNECTED COMPLETELY. NO OTHER SIMILAR COMPLAINTS HAVE BEEN RECEIVED IN THE LAST 12 MONTHS. NO CORRECTIVE ACTIONS ARE BEING IMPLEMENTED AT THIS TIME. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). 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 HAS CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    A CLINICIAN WAS CHECKING THE VITAL SIGNS OF A NEWBORN AND FOUND THERE WAS BLEEDING FROM THE UMBILICAL CORD. THE CLINICIAN APPLIED PRESSURE TO THE CORD TO STOP THE BLEEDING AND REAPPLIED A NEW CLAMP. AN ESTIMATED 5-7 ML OF BLOOD LOSS OCCURRED DUE TO THE CLAMP SLIDING OFF THE NEWBORN. CLINICIAN PLAN FOR AN H&H IN 6HRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1836432 UMBLICAL CORD CLAMP UMBLICAL CORD CLAMP HFW OWENS & MINOR DISTRIBUTION, INC. CLMP101 M088246GD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other