BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACTISEAL VENTRICULAR CATHETER

    MDR report key: 17596152 · Received August 22, 2023

    Report

    Report Number
    3013886523-2023-00282
    Event Type
    Malfunction
    Date Received
    August 22, 2023
    Date of Event
    July 31, 2023
    Report Date
    September 21, 2023
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    K102589
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H4, H6, H10 THE CATHETER (ID (B)(6)) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR)- PRODUCT CODE 82-3073 WITH LOT 7123585, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - A BACTISEAL CATHETER BOX WAS RETURNED, HOWEVER, THERE WAS NO CATHETER IN THE BOX. ROOT CAUSE ANALYSIS- A ROOT CAUSE FOR THE ISSUE OF THE CATHETER WAS CONTAMINATED BECAUSE OF THE ASSOCIATED CONTAMINATED VALVE. IT IS DUE TO A HAIR FOUND INSIDE THE OPENED INNER BLISTER OF A VALVE.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    1 OF 2 REPORTS. OTHER MFG REPORT NUMBER: 3013886523-2023-00283. A FACILITY REPORTED A HAIR IN THE STERILE PACKAGING OF A CERTAS VALVE ((B)(6) ) AND THE BACTISEAL VENTRICULAR CATHETER ((B)(6) ) WAS CONTAMINATED BECAUSE OF THE ASSOCIATED CONTAMINATED VALVE. IT WAS DISCOVERED DURING SETUP FOR A VP SHUNT CASE ON (B)(6) 2023 AND THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE. NO PATIENT CONTACT/INJURY AND THE EVENT DID NOT LED TO SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300786 BACTISEAL VENTRICULAR CATHETER BACTISEAL VENTRICULAR CATHETER JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 7123585

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown