BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEROYAL

    MDR report key: 2669769 · Received July 19, 2012

    Report

    Report Number
    3005011024-2012-00002
    Event Type
    Other
    Date Received
    July 19, 2012
    Date of Event
    May 26, 2012
    Report Date
    June 5, 2012
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    DTL
    PMA / PMN Number
    K810859
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    END USER: THE HOSPITAL REPORTED THAT DURING AN ANGIO PROCEDURE, THEY COULD NOT PASS THE GUIDE WIRE THROUGH THE 18 GAUGE NEEDLE AS IT WAS PARTIALLY OBSTRUCTED. THEY WERE GETTING BLOOD FLOW, BUT COULD NOT PASS THE NEEDLE. DEROYAL: THE DEFECTIVE DEVICE IN THE CATH LAB PACK WAS AN 18 GAUGE NEEDLE MANUFACTURED BY PROCEDURE PRODUCTS, INC. AFTER FURTHER CONTACT WITH THE END USER IT WAS FOUND THAT THEY REUSED THE NEEDLE ON DIFFERENT PARTS OF THE PATIENT'S BODY. BECAUSE OF THIS IT CANNOT BE RULED OUT THAT THE ROOT CAUSE COULD BE DUE TO BLOOD AND/OR TISSUE CLOTTING WITHIN THE NEEDLE FROM REUSE. THE DEFECTIVE NEEDLE WAS RETURNED TO DEROYAL AND FORWARDED ON TO THE SUPPLIER. ADDITIONAL INFORMATION FROM THE USER FACILITY REPORT: DATE USER FACILITY BECAME AWARE OF EVENT: 06/08/2012, MFR PHONE NUMBER: (B)(4), DATE RECEIVED BY MFR: 06/08/2012, (B)(6), THE PATIENT SAFETY MANAGER FOR THE (B)(6) HOSPITAL REPORTED VIA A TELEPHONE CONVERSATION WITH PROCEDURES THAT (B)(6) 2012 WAS THE DATE OF THER INCIDENT. (B)(6) INDICATED THAT A .038 GUIDE WIRE WOULD NOT PASS THROUGH THE NEEDLE, BUT A .025 GUIDE WIRE WOULD PASS THROUGH THE NEEDLE. THE PROCEDURE WAS COMPLETED BY USING A SMALLER SIZE GUIDE WIRE. THE (B)(6) HOSPITAL REPORTED THE INCIDENT TO DEROYAL. GIVEN THAT DEROYAL PURCHASED THE NEEDLE IN QUESTION FROM PROCEDURE PRODUCTS, DEROYAL DIRECTED THE INQUIRY TO PROCEDURE PRODUCTS. (B)(4) OF DEROYAL WAS GIVEN THE PROCEDURE PRODUCTS LOT NUMBER OF 8503-A WHICH COVERS THE NEEDLE IN QUESTION. THE CANNULAS USED TO MANUFACTURE THIS NEEDLE WERE FROM A LOT OF 100,000. THERE IS NO RECORD OF COMPLAINT NOR IS THERE A TRENDING HISTORY OF COMPLAINTS REGARDING THIS LOT OF CANNULAS. UPON OUR INVESTIGATION, WE FOUND THE NEEDLE TO BE WITHIN SPECIFICATION (OD .049 AND ID .039). THE PROXIMAL ORIFICE READILY ACCEPTED A .038 GUIDE WIRE; HOWEVER, THE .038 GUIDE WIRE COULD NOT BE ADVANCED TO THE DISTAL TIP OF THE NEEDLE DUE TO FOREIGN BODY BLOCKAGE. THE BLOCKAGE WAS CONSISTENT IN APPEARANCE WITH BLOOD AND OR TISSUE. NO PATHOLOGY REPORT WAS REQUESTED OF THE BLOCKAGE MATERIAL. FURTHER VISUAL FINDINGS OBSERVED A SLIGHT BEND IN THE DISTAL TIP OF THE CANNULA. FOREIGN BODY BLOCKAGE OF DISTAL TIP OF NEEDLE CANNULA CONSISTENT IN APPEARANCE WITH BLOOD AND TISSUE; SECONDARY FINDING OF SLIGHT BENDING OF DISTAL TIP OF THE CANNULA. BLOCKAGE OCCURRED AFTER NEEDLE WAS MANUFACTURED BY PROCEDURE PRODUCTS.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ANGIO PROCEDURE, THEY COULD NOT PASS THE GUIDE WIRE THROUGH THE 18 GAUGE NEEDLE AS IT WAS PARTIALLY OBSTRUCTED. THEY WERE GETTING BLOOD GLOW, BUT THE WIRE COULD NOT PASS THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEROYAL CATH LAB PACK DTL DEROYAL INDUSTRIES, INC. 89-6644 29033105

    Patients

    Seq Age Sex Outcome Treatment
    1