BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHASIX MESH

    MDR report key: 6619797 · Received June 7, 2017

    Report

    Report Number
    1213643-2017-00339
    Event Type
    Malfunction
    Date Received
    June 7, 2017
    Date of Event
    April 5, 2017
    Report Date
    June 7, 2017
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    OOD
    PMA / PMN Number
    K142818
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO CONTACT INFORMATION PROVIDED ON THE MAUDE EVENT REPORT. DAVOL FIELD ASSURANCE MADE A REQUEST TO THE FDA FOR THE CONTACT INFORMATION HOWEVER CONTACT RESPONDED THAT THEY ARE NOT ABLE TO PROVIDE THAT INFORMATION TO DAVOL. THEREFORE WE ARE UNABLE TO FOLLOW UP DIRECTLY TO REQUEST ADDITIONAL INFORMATION INCLUDING THE LOT NUMBER OF THE IMPLANTED PHASIX DEVICE. THERE WAS NO REPORT OF A PATIENT INJURY OR THAT MEDICAL INTERVENTION WAS PERFORMED. IT WAS ALLEGED IN THE REPORT THAT THE CUSTOMER REQUESTED AND RECEIVED A SHELF LIFE EXTENSION LETTER FROM BARD FOR PHASIX ST CATALOG NO. 1200710 / LOT NO HUAN2028. NOTE: PHASIX ST WAS INITIALLY RELEASED WITH A 12-MONTH SHELF LIFE. LATER ADDITIONAL TEST DATA SUPPORTED A 24-MONTH SHELF LIFE WHICH IS CURRENTLY THE ESTABLISHED EXPIRATION PERIOD FOR PHASIX ST. IT WAS REPORTED THAT A MEMBER OF THE HOSPITAL STAFF INADVERTENTLY ASSUMED THAT 12-MONTH EXTENSION WOULD ALSO BE APPLICABLE TO STANDARD PHASIX MESH IN THEIR INVENTORY THAT HAS A 24-MONTH SHELF LIFE. THIS USER ERROR RESULTED IN THE IMPLANTATION OF AN EXPIRED DEVICE. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED VIA MAUDE EVENT REPORT (MW 5069385) "LABEL ON PACKAGE OF PHASIX ST MESH PKG HAS EXPIRATION DATE OF 02/28/2017. LETTER FROM BARD ATTACHED TO PACKAGE STATES PRODUCT EXPIRATION EXTENDED 24 MONTHS. STAFF INSTRUCTED TO GO BY LETTER. THE REGULAR PHASIX MESH PACKAGE LOOKS SIMILAR TO THE PHASIX ST PKG. EXPIRED PHASIX MESH PLACED IN PT WHEN RN THOUGHT ALL PHASIX MESH HAD 24 MO (MONTH) EXTENSION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399274 PHASIX MESH SURGICAL MESH OOD DAVOL INC., SUB. C.R. BARD, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1