BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CMC CAROTID PACK

    MDR report key: 20608667 · Received November 5, 2024

    Report

    Report Number
    3005011024-2024-00014
    Event Type
    Malfunction
    Date Received
    November 5, 2024
    Date of Event
    October 17, 2024
    Report Date
    February 12, 2025
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    LRO
    UDI-DI
    00749756364454
    PMA / PMN Number
    K842648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A USER FACILITY MEDWATCH REPORT (B)(4) WAS RECEIVED REPORTING HAIR FOUND INSIDE STERILE PACKAGE. THE SAMPLE WAS RECEIVED, AND IT WAS DETERMINED THAT THE HAIR WAS FOUND INSIDE THE VESSEL LOOP PACKAGE THAT DEROYAL PURCHASES FROM ASPEN SURGICAL PRODUCT. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE VESSEL LOOP SUPPLIER ASPEN SURGICAL PRODUCT. THIS INVESTIGATION IS ONGOING AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    A USER FACILITY MEDWATCH REPORT (B)(4) WAS RECEIVED REPORTING HAIR FOUND INSIDE STERILE PACKAGE. THE SAMPLE WAS RECEIVED, AND IT WAS DETERMINED THAT THE HAIR WAS FOUND INSIDE THE VESSEL LOOP PACKAGE THAT DEROYAL PURCHASES FROM ASPEN SURGICAL PRODUCT. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE VESSEL LOOP SUPPLIER ASPEN SURGICAL PRODUCT. ROOT CAUSE WAS DETERMINED BY THE SUPPLIER ASPEN SURGICAL PRODUCT SEVERAL FACTORS WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE PRESENCE OF A HAIR ON THE FINISHED PRODUCT. A NEED WAS IDENTIFIED TO REINFORCE THE PROPER USE OF PERSONAL PROTECTIVE EQUIPMENT (PPE), INCLUDING OPTIMIZING THE GOWNING SEQUENCE. IT WAS ALSO IDENTIFIED THAT THE CURRENT LAYOUT OF THE GOWNING AREA COULD BENEFIT FROM ADJUSTMENTS THAT WOULD FAVOR A MORE EFFICIENT DISTRIBUTION AND ALLOW FOR MORE EFFECTIVE SUPERVISION OF THIS PROCESS. THE FOLLOWING CORRECTIVE AND PREVENTIVE ACTIONS HAVE BEEN TAKEN BY ASPEN SURGICAL PRODUCT UPDATING AND STRENGTHENING OF THE GOWNING INSTRUCTION 1078686. UPDATE OF VISUAL AIDS IN AND OUT OF AREA 1076820 WHERE -IMPLEMENTING CHANGES IN THE GOWNING PROCESS, AS WELL AS A SECOND USE OF LINT ROLLER. TRAINING OF PERSONNEL IN THE GOWNING PROCESS 1078686. CHANGE OF MATERIAL IN THE GOWNS USED IN THE AREA FROM TYVEK TO POLYESTER, WHICH PREVENTS HAIR AND PARTICLES FROM ADHERING TO THE SURFACE OF THE GOWN. REDESIGN OF THE AREA GOWNING LAYOUT. MODIFICATION OF THE CONTROL PLAN TO ADD VISUAL INSPECTION OF HAIR CONTAMINATION. QUALITY ALERT ISSUED. PRODUCTION PERSONNEL WERE NOTIFIED OF THE REPORTED COMPLAINT. REPLACEMENT OF AIR PURIFIER SPONGES. CHANGE OF CLEANING FREQUENCY FROM ONCE TO TWICE, ONCE IN THE MORNING BEFORE STARTING SHIFT AND ONCE AFTER LUNCH. DEROYAL CONDUCTED RE-TRAINING ON THE WORKORDER PROCEDURE TO ENSURE THE EMPLOYEES ARE AWARE OF THIS COMPLAINT AND THE IMPORTANCE OF CHECKING PRODUCTS FOR HAIR/DEBRIS/DEFECTS. PRODUCTION RECORDS WERE REVIEWED, AND NO ISSUES WERE FOUND. AN INVENTORY CHECK OF THE VESSEL LOOPS WAS MADE BY DEROYAL, A TOTAL OF 50 OF THE 1260701 WAS INSPECTED, AND NO DISCREPANCIES WERE IDENTIFIED DURING THE INSPECTION. THIS INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    HAIR FOUND INSIDE STERILE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1796430 CMC CAROTID PACK GENERAL SURGERY TRAY (KIT) LRO DEROYAL INDUSTRIES, INC. 89-10540 60953129 00749756364454

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown