BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURO PACK

    MDR report key: 18324227 · Received December 14, 2023

    Report

    Report Number
    3005011024-2023-00039
    Event Type
    Malfunction
    Date Received
    December 14, 2023
    Date of Event
    December 4, 2023
    Report Date
    February 12, 2024
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    LRO
    PMA / PMN Number
    K842648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A COMPLAINT WAS RECEIVED ON 12/04/2023 10 ML GREEN PLUNGER SYRINGE CRACKED UNDER PRESSURE AND BLOOD WAS EXPELLED OVER THE FIELD AND ONTO THE MEDICAL DOCTORS FACE. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE SYRINGE SUPPLIER PROCEDURE PRODUCTS, INC. THE SAMPLE HAS BEEN RETURNED TO DEROYAL FOR EVALUATION. 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 COMPLAINT WAS RECEIVED ON 12/04/2023 10 ML GREEN PLUNGER SYRINGE CRACKED UNDER PRESSURE AND BLOOD WAS EXPELLED OVER THE FIELD AND ONTO THE MEDICAL DOCTORS FACE. THE SAMPLE HAS BEEN RETURNED WITHIN A BIOHAZARD BAG AND DETERMINED TO BE CONTAMINATED THEREFORE, IT WAS UNABLE TO BE RETURNED TO THE SUPPLIER FOR EVALUATION. HOWEVER, A PICTURE OF THE BAGGED SAMPLE WAS SENT TO THE SUPPLIER. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE SYRINGE SUPPLIER PROCEDURE PRODUCTS, INC. THE TRUE ROOT CAUSE WAS UNABLE TO BE DETERMINED BY THE SUPPLIER PROCEDURE PRODUCTS, INC. DUE TO THE SYRINGE HAVING UNDERGONE ADDITIONAL PROCESSING BY DEROYAL SUCH AS STERILIZATION. POTENTIAL ROOT CAUSE BULK, NON-STERILE SYRINGES ARE INHERENTLY SUSCEPTIBLE TO DAMAGE THAT CAN OCCUR DURING SHIPPING, STORAGE, HANDLING, PLACEMENT INTO KITS, STERILIZATION, ADDITIONAL PROCESSING, ETC. WE HIGHLY RECOMMEND THOROUGH INCOMING INSPECTION ACTIVITIES TO ENSURE DAMAGED SYRINGES ARE IDENTIFIED PRIOR TO USE. PROCEDURE PRODUCTS, INC. HAS HISTORICAL TESTING DATA FOR PRESSURE FAILURE AT THE GASKET, WHICH AVERAGES >315 PSI FOR THESE SYRINGES. NONE OF THE TESTED BARRELS RUPTURED BEFORE GASKET LEAKAGE RELIEVED THE INTERNAL PRESSURE. WE HAVE NOT SEEN ANY EVIDENCE THAT WOULD INDICATE THIS FAILURE IS PART OF A LARGER TREND. WHILE WE PROVIDE SYRINGES TO DEROYAL IN BULK, WE ALSO OFFER A VARIETY OF STERILE SYRINGES USING THE SAME BARRELS. OF THE LAST 70,000 SYRINGES SOLD IN STERILE FORMAT WE HAVE NOT BEEN MADE AWARE OF A SINGLE FAILURE OF THIS NATURE. DUE TO THE ROOT CAUSE FINDING THERE WERE NO CORRECTIVE AND PREVENTIVE ACTIONS TAKEN BY PROCEDURE PRODUCTS, INC. PRODUCTION RECORDS WERE REVIEWED BY DEROYAL, AND NO ISSUES WERE FOUND. AN INVENTORY CHECK OF THE SYRINGE WAS MADE BY DEROYAL, A TOTAL OF (B)(4) OF THE 5-17181 WERE 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

    10 ML GREEN PLUNGER SYRINGE CRACKED UNDER PRESSURE AND BLOOD WAS EXPELLED OVER THE FIELD AND ONTO THE MEDICAL DOCTORS FACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327281 NEURO PACK GENERAL SURGERY TRAY (KIT) LRO DEROYAL INDUSTRIES, INC. 89-8294 59494973

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown