BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND PACK ESC/ACS

    MDR report key: 20421015 · Received October 10, 2024

    Report

    Report Number
    3003419114-2024-00003
    Event Type
    Malfunction
    Date Received
    October 10, 2024
    Date of Event
    September 12, 2024
    Report Date
    February 6, 2025
    Manufacturer
    AMERICAN CONTRACT SYSTEMS, INC.
    Product Code
    OJH
    UDI-DI
    00191072209658
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR COMPLAINT LOT NUMBER WAS REVIEWED. THE PRODUCT LOT MET ALL MANUFACTURING REQUIREMENTS PRIOR TO RELEASE. NO REWORK OR SPECIAL CONDITIONS WERE REPORTED. THERE ARE ENVIRONMENTAL CONTROLS IN PLACE AT THE MANUFACTURING SITE INCLUDING POSITIVE PRESSURE ENVIRONMENT, CLEANING PROCEDURES, NON-VIABLE PARTICLE MONITORING AND GOWNING PROCEDURES TO MINIMIZE OPPORTUNITY FOR FOREIGN MATERIAL OCCURRENCE. ONE COMPLAINT PHOTO PROVIDED APPEARS TO CONTAIN SOME FOREIGN MATERIAL: HOWEVER, IT'S DIFFICULT TO IDENTIFY THROUGH A PHOTO REVIEW. NO SAMPLE WAS PROVIDED BY THE COMPLAINANT. THERE ARE SOME PRIOR COMPLAINTS RECEIVED FOR FOREIGN MATERIAL OVER THE PAST 12 MONTHS; HOWEVER, NONE OF THESE REPORT METAL FOREIGN MATERIAL SIMILAR TO THIS OCCURRENCE. THE SITE HAS NOTIFIED MANUFACTURING PERSONNEL OF THE COMPLAINT TO MONITOR FOR METAL PARTICULATE PRESENCE DURING ASSEMBLY. THE SITE WILL CONTINUE TO MONITOR FOR ANY ADDITIONAL COMPLAINT RECEIPT FOR THIS ISSUE. 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

    THE PRODUCT INVOLVED IN THE EVENT WAS NOT RETURNED FOR EVALUATION. 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.

    Description of Event or Problem · 0

    FOREIGN DEBRIS WAS FOUND IN THE FOLD OF THE DRAPE WHICH WAS WITHIN ACS CONVENIENCE KIT. THE DEBRIS WAS DISCOVERED WHILE PATIENT WAS UNDER ANESTHESIA BUT BEFORE INCISION. THE STERILE FIELD WAS DEEMED CONTAMINATED. THERE WAS A SIGNIFICANT DELAY WHILE THE ROOM WAS CLEANED, AND A NEW STERILE FIELD WAS SET UP WITH NEW SUPPLIES AND INSTRUMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343597 HAND PACK ESC/ACS HAND PACK ESC/ACS OJH AMERICAN CONTRACT SYSTEMS, INC. EVHD34 12-7124011 00191072209658

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown