BEUDAMED
    FDA Adverse Event Other Summary report: N

    ONE PART SELDINGER NEEDLE WITHOUT BASEPLATE WITH

    MDR report key: 2669674 · Received June 17, 2012

    Report

    Report Number
    3020778-2012-00001
    Event Type
    Other
    Date Received
    June 17, 2012
    Date of Event
    May 26, 2012
    Report Date
    June 8, 2012
    Manufacturer
    PROCEDURE PRODUCTS, INC.
    Product Code
    DRE
    PMA / PMN Number
    K810859
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) FOR THE (B)(6) HOSPITAL REPORTED VIA A TELEPHONE CONVERSATION WITH PROCEDURE PRODUCTS THAT (B)(6) 2012 WAS THE DATE OF THE INCIDENT. (B)(6) INDICATED THAT A 0.38 GUIDE WIRE WOULD NOT PASS THROUGH THE NEEDLE, BUT A 0.25 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 MFR THIS NEEDLE WERE FROM A LOT OF (B)(4). 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 0.38 GUIDE WIRE; HOWEVER, THE 0.38 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. ADD'L NOTE: THIS ITEM HAS BEEN INSIDE A CUSTOM-PACKED TRAY SINCE THE TRAY WAS CREATED BY DISTRIBUTOR IN APRIL 2009.

    Description of Event or Problem · 1

    A DEFECTIVE ACCESS NEEDLE LED TO ADD'L ARTERIAL PUNCTURES FOR PT WITH ACUTE MT REQUIRING EMERGENT CARDIAC CATH. THE NEEDLE FOR ACCESS WOULD NOT PERMIT PASSAGE OF A 0.35 WIRE. BOTH FEMORAL ARTERIES WERE CANNULATED WITHOUT SUCCESS. THE DEFECTIVE NEEDLE WAS REALIZED WHEN THE 0.35 WIRE ALSO WOULD NOT PASS IN THE BRACHIAL ARTERY. BUT A 0.25 WIRE DID PASS. THE NEEDLE WAS INSPECTED AND FOUND TO BE DEFECTIVE. THE PT DID NOT EXPERIENCE AN UNTOWARD OUTCOME FROM THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE PART SELDINGER NEEDLE WITHOUT BASEPLATE WITH NEEDLE SELDINGER NO BASE PLATE 18 GA X 2 3/4 IN DRE PROCEDURE PRODUCTS, INC. 31-1827

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other