BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GELFOAM STERILE SPONGE SIZE 100 X 6

    MDR report key: 1210051 · Received October 22, 2008

    Report

    Report Number
    1810189-2008-00003
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Report Date
    October 17, 2008
    Manufacturer
    PFIZER INC.
    Product Code
    LMF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE IT CANNOT BE DETERMINED HOW THE PACKAGES WERE HANDLED ONCE THE PRODUCT WAS NO LONGER UNDER PFIZER CONTROL, NONE OF THE RETURNED PACKAGES EXHIBITED EVIDENCE OF MISHANDLING. INVESTIGATION IS ONGOING INTO POTENTIAL ROOT CAUSE AND CORRECTIVE ACTION TO PREVENT SPONTANEOUS OPENING.

    Description of Event or Problem · 1

    A HOSPITAL PURCHASING AGENT REPORTED SOME GELFOAM POUCHES WERE NOT SEALED AND HAD GAPS WHERE THE GLUE HAS COME APART AND SOME OF THE POUCHES WERE COMPLETELY OPENED. THE ASSOCIATED PRODUCT HAD NOT BEEN USED IN A PT. TWENTY TWO GELFOAM POUCHES IN TWO PLASTIC ZIPLOCK BAGS WERE RETURNED TO PFIZER BY THE COMPLAINANT, AND WERE EVALUATED AT THE MANUFACTURING SITE ON SEPT 24, 2008. THE INVESTIGATOR FOUND TWO OF 10 POUCHES WITH A SMALL CREASE IN THE LEFT HAND CORNER OF THE BACK SIDE OF THE POUCH IN THE FIRST BAG. AT THE CREASE, THERE WAS A SMALL OPENING OF THE POUCH. THE SECOND ZIPLOCK CONTAINED 12 POUCHES AND THREE POUCHES EXHIBITED A CREASE IN THE LEFT HAND CORNER OF THE BACK SIDE OF THE POUCH WITH A SMALL OPENING, AND TWO POUCHES WITH A SMALL OPENING AT THE TOP RIGHT HAND CORNER OF THE POUCH, VIEWING FROM THE BACKSIDE. TWELVE (12) RETAINED SAMPLES FROM LOT 0ATPJ WERE EVALUATED AND FOUND TO HAVE INTACT OUTER PACKAGE SEALS. THIS REPORT IS BEING MADE DUE TO THE APPARENT COMPROMISE IN THE INTEGRITY OF THE SEAL IN THE OUTER PACKAGE WHICH COULD CONTRIBUTE TO A COMPROMISE IN STERILITY OF THE INNER PACKAGE OF GELFOAM, DETECTED AS A PARTIAL SPONTANEOUS OPENING IN THE SAMPLES RETURNED TO PFIZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GELFOAM STERILE SPONGE SIZE 100 X 6 ABSORBABLE HEMOSTATIC AGENT LMF PFIZER INC. NA 0APTJ

    Patients

    Seq Age Sex Outcome Treatment
    1