BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOGRAPHY PACK

    MDR report key: 6545985 · Received May 4, 2017

    Report

    Report Number
    3005011024-2017-00007
    Event Type
    Malfunction
    Date Received
    May 4, 2017
    Date of Event
    April 13, 2017
    Report Date
    January 19, 2018
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    OEQ
    PMA / PMN Number
    ENFORCEMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: THE CONVENIENCE KIT COMPONENT IS SUPPLIED TO DEROYAL BY BD. THEREFORE, A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO BD. IN ITS RESPONSE, THE SUPPLIER STATED THAT THE ROOT CAUSE IS UNKNOWN. NO ISSUES WERE REPORTED DURING THE MANUFACTURING OF THE REPORTED BATCH. WITHOUT A SAMPLE TO EVALUATE, IT IS NOT POSSIBLE TO CONCLUDE WHETHER THE DEFECT OCCURRED DURING MANUFACTURING OR POST-MANUFACTURE HANDLING. CORRECTIVE ACTION: IN ITS SCAR RESPONSE, BD STATED NO CORRECTIVE ACTIONS ARE NECESSARY AT THIS TIME. AN INTERNAL COMPLAINT (CALL 40590) WAS RECEIVED INDICATING THAT A 10CC SYRINGE CONTAINED WITHIN AN ANGIOGRAPHY PACK (PART NUMBER (B)(4) SPLIT DOWN THE SIDE, ALLOWING FACILITY STAFF TO BECOME EXPOSED TO BLOOD. UPON FURTHER DISCUSSION WITH THE CUSTOMER, IT WAS FOUND THAT EVEN THOUGH THE SURGEON AND TECH WERE EXPOSED TO BLOOD DURING THE PROCEDURE, NO MEDICAL ATTENTION WAS NEEDED. A SAMPLE WAS NOT AVAILABLE FOR RETURN. THE WORK ORDER WAS REVIEWED FOR POSSIBLE DISCREPANCIES. NO DISCREPANCIES WERE IDENTIFIED. LOT MAPPING IDENTIFIED THE AFFECTED RAW MATERIAL AS (B)(4) (10CC SYRINGE LUER SLIP, LOT 6204645). THIS RAW MATERIAL COMPONENT IS SUPPLIED TO DEROYAL BY BECTON-DICKINSON. A SCAR WAS ISSUED TO BD ON (B)(6) 2017. A RESPONSE HAS BEEN RECEIVED. THE 2014-2016 SCAR AND SUPPLIER NOTIFICATION LETTER LOGS WERE REVIEWED FOR SIMILAR COMPLAINTS. NO SIMILAR COMPLAINTS WERE IDENTIFIED. PREVENTIVE ACTION: IN ITS SCAR RESPONSE, BD STATED A PREVENTIVE ACTION IS NOT RECOMMENDED AT THIS TIME. THE INVESTIGATION IS COMPLETE AT THIS TIME. IF NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED. .

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY AN INTERNAL COMPLAINT (B)(4) WAS RECEIVED INDICATING THAT A 10CC SYRINGE CONTAINED WITHIN AN ANGIOGRAPHY PACK (PART NUMBER 89-7019) SPLIT DOWN THE SIDE, ALLOWING FACILITY STAFF TO BECOME EXPOSED TO BLOOD. A SAMPLE WAS NOT AVAILABLE FOR RETURN. THE SYRINGE IS SUPPLIED TO DEROYAL BY (B)(4). THEREFORE, A SUPPLIER CORRECTIVE ACTION REQUEST WAS ISSUED TO (B)(4) ON APRIL 20, 2017. A RESPONSE IS DUE JUNE 1, 2017. THE INVESTIGATION IS ONGOING AT THIS TIME. WHEN NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    A 10CC SYRINGE CONTAINED WITHIN THE ANGIOGRAPHY PACK SPLIT DOWN THE SIDE, ALLOWING THE SURGEON AND TECH TO BE EXPOSED TO BLOOD.

    Description of Event or Problem · 1

    A 10CC SYRINGE CONTAINED WITHIN THE ANGIOGRAPHY PACK SPLINT DOWN THE SIDE, ALLOWING THE SURGEON AND TECH TO BE EXPOSED TO BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326894 ANGIOGRAPHY PACK ANGIOGRAPHY/ANGIOPLASTY KIT OEQ DEROYAL INDUSTRIES, INC. 89-7019 44357626

    Patients

    Seq Age Sex Outcome Treatment
    1