BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CNRV CARDIAC CATH SET-UP PACK

    MDR report key: 18886417 · Received March 12, 2024

    Report

    Report Number
    3005011024-2024-00009
    Event Type
    Malfunction
    Date Received
    March 12, 2024
    Date of Event
    October 28, 2023
    Report Date
    July 22, 2024
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    OEQ
    UDI-DI
    00749756364348
    PMA / PMN Number
    ENFDISC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A USER FACILITY MEDWATCH REPORT (B)(4) WAS RECEIVED ON 03/04/2024 REPORTING MANIFOLD PIECE CRACKED AND ALLOWING AIR TO CLOSED SYSTEM FOR 89-10149 LOT # 59673980. HOWEVER, THE LOT NUMBER WAS DETERMINED TO BE FOR 89-10519. A PICTURE OF THE SAMPLE WAS PROVIDED. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE MANIFOLD SUPPLIER MERIT MEDICAL SYSTEMS, INC. THE TRUE ROOT CAUSE WAS UNABLE TO BE DETERMINED BY THE SUPPLIER MERIT MEDICAL SYSTEM, INC. HOWEVER, POTENTIAL CAUSES FOR LEAKING HAVE BEEN DETERMINED TO BE CAUSED BY CRAZING/CRACKING. POTENTIAL CAUSES THAT CAN LEAD TO CRACKS HAVE BEEN DETERMINED TO BE FROM BENDING/HITTING/MISHANDLING THE COMPONENTS, BONDING ISSUES, OVERTIGHTENING, CHEMICAL INTERACTION BETWEEN HARD-TO-HARD COMPONENTS AND EXTREME TEMPERATURES. THIS DEFECT COULD HAVE OCCURRED AT ANY TIME FROM THE POINT OF MANUFACTURE TO THE POINT OF END USER. WE COULD NOT DETERMINE WHEN, WHERE, OR HOW THE DAMAGE OCCURRED IN THIS CASE. DUE TO THE ROOT CAUSE FINDING THERE WERE NO CORRECTIVE AND PREVENTIVE ACTIONS TAKEN BY MERIT MEDICAL SYSTEM, INC. PRODUCTION RECORDS WERE REVIEWED BY DEROYAL, AND NO ISSUES WERE FOUND. AN INVENTORY CHECK OF THE MANIFOLD WAS MADE BY DEROYAL, A TOTAL OF (B)(4) OF THE (B)(4) WERE VISUALLY 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.

    Additional Manufacturer Narrative · 0

    A USER FACILITY MEDWATCH REPORT (#(B)(4)) WAS RECEIVED ON 03/04/2024 REPORTING MANIFOLD PIECE CRACKED AND ALLOWING AIR TO CLOSED SYSTEM FOR 89-10149 LOT # 59673980. HOWEVER, THE LOT NUMBER WAS DETERMINED TO BE FOR 89-10519. A PICTURE OF THE SAMPLE WAS PROVIDED. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE MANIFOLD SUPPLIER MERIT MEDICAL SYSTEMS, INC. THE TRUE ROOT CAUSE WAS UNABLE TO BE DETERMINED BY THE SUPPLIER MERIT MEDICAL SYSTEM, INC. HOWEVER, POTENTIAL CAUSES FOR LEAKING HAVE BEEN DETERMINED TO BE CAUSED BY CRAZING/CRACKING. POTENTIAL CAUSES THAT CAN LEAD TO CRACKS HAVE BEEN DETERMINED TO BE FROM BENDING/HITTING/MISHANDLING THE COMPONENTS, BONDING ISSUES, OVERTIGHTENING, CHEMICAL INTERACTION BETWEEN HARD-TO-HARD COMPONENTS AND EXTREME TEMPERATURES. THIS DEFECT COULD HAVE OCCURRED AT ANY TIME FROM THE POINT OF MANUFACTURE TO THE POINT OF END USER. WE COULD NOT DETERMINE WHEN, WHERE, OR HOW THE DAMAGE OCCURRED IN THIS CASE. DUE TO THE ROOT CAUSE FINDING, THERE WERE NO CORRECTIVE AND PREVENTIVE ACTIONS TAKEN BY MERIT MEDICAL SYSTEM, INC. PRODUCTION RECORDS WERE REVIEWED BY DEROYAL, AND NO ISSUES WERE FOUND. AN INVENTORY CHECK OF THE MANIFOLD WAS MADE BY DEROYAL, A TOTAL OF (B)(4) WERE VISUALLY 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.

    Additional Manufacturer Narrative · 0

    A USER FACILITY MEDWATCH REPORT (B)(4) WAS RECEIVED ON 03/04/2024 REPORTING MANIFOLD PIECE CRACKED AND ALLOWING AIR TO CLOSED SYSTEM FOR 89-10149 LOT # 59673980. HOWEVER, THE LOT NUMBER WAS DETERMINED TO BE FOR 89-10519. THE SAMPLE HAS NOT BEEN RETURNED TO DEROYAL FOR EVALUATION AT THIS TIME. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE MANIFOLD SUPPLIER MERIT MEDICAL SYSTEMS, INC. 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

    MANIFOLD PIECE CRACKED AND ALLOWING AIR TO CLOSED SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1385363 CNRV CARDIAC CATH SET-UP PACK ANGIOGRAPHY/ANGIOPLASTY KIT OEQ DEROYAL INDUSTRIES, INC. 89-10519 59673980 00749756364348

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown