BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW PICC COMPONENT: 3 FR X 21-1/2" (55 CM)

    MDR report key: 10946692 · Received December 4, 2020

    Report

    Report Number
    9680794-2020-00483
    Event Type
    Malfunction
    Date Received
    December 4, 2020
    Date of Event
    November 9, 2020
    Report Date
    November 11, 2020
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    LJS
    PMA / PMN Number
    K061289
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED ONE PRODUCT LIDSTOCK AND PEEL-AWAY SHEATH FOR EVALUATION. FURTHER ANALYSIS OF THE REPORTED KIT REVEALED A PEEL-AWAY SHEATH IS NOT PROVIDED WITHIN THIS KIT. MANUFACTURING DETERMINED THAT THE RETURNED SHEATH WAS PRODUCT CODE K-01351-028B, THEREFORE THE INVESTIGATION WILL BE PERFORMED ACCORDINGLY. VISUAL EXAMINATION REVEALED THE SHEATH TABS WERE BROKEN AND SEPARATED FROM THE SHEATH BODY. A SMALL PORTION OF THE TABS WERE STILL SECURED TO THE EXTRUSION. THE TOTAL LENGTH OF THE SHEATH BODY MEASURED TO BE 2.75" WHICH IS WITHIN SPECIFICATIONS OF 2.68"- 2.81" PER PRODUCT DRAWING. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS A PEEL-AWAY SHEATH IS NOT INCLUDED IN THE PRODUCT CODE PROVIDED BY THE CUSTOMER. THE CUSTOMER REPORT OF BROKEN SHEATH TABS WAS CONFIRMED BY COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. THE SAMPLE PASSED ALL RELEVANT DIMENSIONAL INSPECTION. BASED ON THE CONDITION OF THE SAMPLE RECEIVED, MANUFACTURING CAUSED OR CONTRIBUTED TO THIS EVENT. A NON-CONFORMANCE REQUEST HAS BEEN INITIATED TO FURTHER INVESTIGATE THIS ISSUE.

    Description of Event or Problem · 0

    THE COMPLAINT IS REPORTED AS: "IT WAS REPORTED THAT: SUCCESSFUL INSERTION OF THE COMPONENT BUT WHEN WENT TO SNAP OFF THE WINGS OF THE PEEL AWAY SHEATH FIRST ONE WING SNAPPED OFF COMPLETELY, THEN THE OTHER ONE SNAPPED OFF. THEN THE INSERT NEEDED TO USE HER NAIL TO SLIT OPEN THE REMAINING OF THE PEEL AWAY SHEATH TO TRY TO REMOVE IT FROM THE PATIENT. IT WAS ALSO NOTED THAT THE INTRODUCER WAS VERY DIFFICULT TO REMOVE FROM THE PEEL AWAY SHEATH." NO PATIENT HARM REPORTED. THE DEVICE WAS REMOVED IT ITS ENTIRETY. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Additional Manufacturer Narrative · 1

    QN#: (B)(4).

    Description of Event or Problem · 1

    THE COMPLAINT IS REPORTED AS: "IT WAS REPORTED THAT: SUCCESSFUL INSERTION OF THE COMPONENT BUT WHEN WENT TO SNAP OFF THE WINGS OF THE PEEL AWAY SHEATH FIRST ONE WING SNAPPED OFF COMPLETELY, THEN THE OTHER ONE SNAPPED OFF. THEN THE INSERTER NEEDED TO USE HER NAIL TO SLIT OPEN THE REMAINING OF THE PEEL AWAY SHEATH TO TRY TO REMOVE IT FROM THE PATIENT. IT WAS ALSO NOTED THAT THE INTRODUCER WAS VERY DIFFICULT TO REMOVE FROM THE PEEL AWAY SHEATH." NO PATIENT HARM REPORTED. THE DEVICE WAS REMOVED IT ITS ENTIRETY. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1409247 ARROW PICC COMPONENT: 3 FR X 21-1/2" (55 CM) CATHETER, INTRAVASCULAR, THER LJS ARROW INTERNATIONAL INC. 14F17H0349

    Patients

    Seq Age Sex Outcome Treatment
    1