BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1-PIECE NEEDLE .035 19G 7.0

    MDR report key: 14567483 · Received June 1, 2022

    Report

    Report Number
    9681709-2022-00001
    Event Type
    Malfunction
    Date Received
    June 1, 2022
    Date of Event
    April 27, 2022
    Report Date
    July 8, 2022
    Manufacturer
    CORDIS CORPORATION
    Product Code
    GCB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 0

    AS REPORTED, THE CUSTOMER STATED THEY COULD NOT THREAD THE GUIDEWIRE THROUGH THE INTRODUCER NEEDLE (1-PIECE NEEDLE .035 19G 7.0.) THE GUIDEWIRE WAS EXCHANGED, AND IT WAS STILL NOT POSSIBLE. THE NEEDLE WAS DETACHED FROM HUB. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT 20B101 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. WITHOUT THE RETURN OF THE DEVICE OR IMAGES FOR ANALYSIS, THE REPORTED CUSTOMER EVENTS ¿NEEDLE- OBSTRUCTED AND NEEDLE- FRACTURED-SEPARATED¿ COULD NOT BE CONFIRMED. THE LIMITED INFORMATION PROVIDED SUGGESTS THE INABILITY TO THREAD THE GUIDEWIRE THROUGH THE NEEDLE MAY HAVE BEEN CAUSED BY DAMAGES TO THE NEEDLE AND/OR IMPROPER GUIDEWIRE SELECTION. THE EXACT CAUSE OF THE DAMAGES TO THE NEEDLE CANNOT BE CONCLUSIVELY DETERMINED WITH THE INFORMATION PROVIDED. STORAGE OR HANDLING FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. USERS ARE TRAINED TO INSPECT FOR SIGNS OF DAMAGE PRIOR TO AND DURING USE. ANY PRODUCT WITH DAMAGE IS NOT TO BE USED. INFORMATION FOR SAFETY IS PROVIDED IN THE PRODUCTS LABELING WITH THE INTENT TO MAKE THE USER AWARE OF THE RISKS. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), ALTHOUGH NOT INTENDED AS A MITIGATION OF RISK, ¿DO NOT USE IF ANGIOGRAPHIC NEEDLE IS DAMAGED. RECOMMENDED PROCEDURE 1. IDENTIFY THE INSERTION SITE AND PREPARE THE SITE USING PROPER ASEPTIC TECHNIQUE AND LOCAL ANESTHESIA AS REQUIRED. 2. REMOVE THE ANGIOGRAPHIC NEEDLE FROM PACKAGE USING PROPER ASEPTIC TECHNIQUE. 3. FLUSH THE ANGIOGRAPHIC NEEDLE WITH HEPARINIZED SALINE OR A SUITABLE ISOTONIC SOLUTION. 4. INSERT THE ANGIOGRAPHIC NEEDLE USING STANDARD TECHNIQUE. 5. INSERT AN APPROPRIATELY SIZED MINI-GUIDEWIRE TO MAINTAIN THE ACCESS SITE AND CAREFULLY REMOVE THE ANGIOGRAPHIC NEEDLE.¿ BASED ON THE INFORMATION AVAILABLE AND THE PHR REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE DESIGN OR MANUFACTURING PROCESS. THEREFORE, NO PREVENTATIVE OR CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 0

    AS REPORTED, THE CUSTOMER STATED THAT THEY COULD NOT ENTER THE GUIDEWIRE THROUGH THE INTRODUCER NEEDLE (1-PIECE NEEDLE .035 19G 7.0.) THE GUIDEWIRE WAS EXCHANGED. HOWEVER;. IT WAS STILL NOT POSSIBLE. THE NEEDLE WAS DETACHED FROM HUB. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 0

    MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION AND THE REQUESTS HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264617 1-PIECE NEEDLE .035 19G 7.0 NEEDLE, CATHETER GCB CORDIS CORPORATION 20B101

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown