BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURG PAT XRAY 1/2X2 -200

    MDR report key: 18530060 · Received January 17, 2024

    Report

    Report Number
    3014334038-2024-00007
    Event Type
    Malfunction
    Date Received
    January 17, 2024
    Date of Event
    December 21, 2023
    Report Date
    January 28, 2025
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    HBA
    PMA / PMN Number
    K880402
    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, H11. THE SURGICAL PATTIES (ID 801406) WERE NOT RETURNED FOR EVALUATION; HOWEVER, IMAGES WERE PROVIDED: DHR - NO ANOMALIES OR NON-CONFORMANCES WERE IDENTIFIED. FAILURE ANALYSIS - EVALUATION OF THE PROVIDED IMAGES CONFIRMS THE PRESENCE OF THE HAIR STRAND, ON THE CARD, AS REPORTED. ROOT CAUSE - A POTENTIAL CAUSE OF THE CONTAMINANT MAY HAVE BEEN RELATED TO A FAILURE OF THE OPERATOR'S HAIR NET.

    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.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D9, G3, G6, H2, H3, H6, H11. INVESTIGATION FINDINGS UPDATE: FAILURE ANALYSIS / ROOT CAUSE - THE SAMPLE WAS NOT RETURNED BUT AN IMAGE WAS PROVIDED. COMPLAINT DESCRIPTION STATES THAT A HAIR WAS FOUND IN A SEALED POUCH HOWEVER THE COMPLAINT IMAGES ARE OF AN OPENED PRODUCT WHICH HAS BEEN REMOVED FROM THE POUCH. SINCE THE SAMPLE WAS OPENED THE COMPLAINT CANNOT BE CONFIRMED. IT CANNOT BE DETERMINED THAT THE HAIR WAS NOT INTRODUCED AFTER OPENING THE PRODUCT.

    Description of Event or Problem · 0

    A FACILITY REPORTED THAT BEFORE UNPACKING THE SURGICAL PATTIES (ID (B)(6)) THE PHYSICIAN FOUND THAT THE PATTIES INSIDE WERE CONTAMINATED (WITH A HAIR INSIDE THE UNOPENED STERILIZED POUCH). THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE AND THE EVENT LED TO 15 MINUTES SURGICAL DELAY, NO PATIENT CONSEQUENCES.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1675619 SURG PAT XRAY 1/2X2 -200 SURGICAL PATTIES HBA INTEGRA LIFESCIENCES MANSFIELD 6470402

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown