BEUDAMED
    FDA Adverse Event Other Summary report: N

    WARM PACK, INSTANT, GEL, 6"X6"

    MDR report key: 1240850 · Received November 12, 2008

    Report

    Report Number
    1417592-2008-00039
    Event Type
    Other
    Date Received
    November 12, 2008
    Report Date
    November 11, 2008
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT A PACK EXPLODED UPON ACTIVATION. THE PACK WAS ACTIVATED BY A PT'S FAMILY MEMBER AND THE CONTENTS WENT INTO HIS EYES. HE WENT TO THE ER WHERE THE EYES WERE FLUSHED AND HE WAS DISCHARGED. NO SERIOUS INJURY REPORTED. THE ACTUAL SAMPLE INVOLVED IN THE INCIDENT WAS NOT RETURNED, BUT THE ACCOUNT ALLOWED PHOTOS TO BE TAKEN. SAMPLES FROM THE SAME LOT WERE RETURNED. INSPECTION RECORDS AND EQUIPMENT VALIDATION REPORTS THAT RELATED TO THE LOT CODE WERE REVIEWED AND NO ABNORMALITIES WERE IDENTIFIED DURING THE PRODUCTION RUNS. AFTER WE DETERMINED THAT NO ABNORMALITIES WERE PRESENT DURING MANUFACTURING, WE TRIED TO RECREATE THE INCIDENT WITH THE PRODUCT. OUR REVIEW OF THE DIGITAL PICTURES TAKEN OF THE PRODUCT INVOLVED IN THE INCIDENT INDICATED THE OUTER POUCH SPLIT JUST BELOW THE TOP SEAL. WE TESTED THE INTEGRITY OF THE OUTER POUCH FILM FOLLOWING THE HEAT SEALING. EVEN THROUGH THE EQUIPMENT HAD BEEN CHECKED AND PASSED VALIDATION THE DAY OF MANUFACTURING, WE CONFIRMED THE PRODUCT WAS NOT BEING COMPROMISED. TO DO THIS, WE MADE 20 SAMPLES OF THE PRODUCT WITH THE HEAT ON THE SEALERS TURNED UP TO THE MAXIMUM. 10 SAMPLES WERE SEALED ONCE, 5 WERE SEALED TWICE AND 5 WERE TRIPLE SEALED. THE TRIPLE SEALED PRODUCT RESULTED IN A SEAL THAT WAS ALMOST TRANSPARENT (AND THEREFORE WEAK). THE SAMPLES WERE TESTED BY SLAMMING THEM ONTO A BARE CONCRETE FLOOR; NO BURSTING OCCURRED. THE SAME SAMPLES WERE THEN PRESSURE TESTED AT 600 PSI EACH (500 PSI IS OUR SPECIFICATION); NO BURSTING OCCURRED. AFTER THESE SERIES OF TESTS, NO CONCLUSION WAS MADE THAT INDICATED THE TEARING WAS CAUSED BY OVERHEATING THE SEAL OF THIS PRODUCT. WE WERE ONLY ABLE TO RECREATE A MATERIAL TEAR BY LAYING 4 SAMPLES FLAT ON THE FLOOR AND ACTIVATING THE PACKS BY STOMPING ON THEM. THREE SAMPLES BURST AT THE TOP SEAL USING THIS ACTIVATION METHOD. IN A FINAL EFFORT, WE TRIED TO RECREATE THE PRODUCT FAILURE BY FORCEFULLY ACTIVATING THE PRODUCT AND PUSHING THE INNER CONTENTS UP TOWARD THE TOP SEAL. IN BOTH CASES THE INNER FLUID BAG BURST BEFORE ANY SIGNS OF STRESS ON THE SEAL APPEARED. GIVEN THE RESULTS OF THE VARIOUS EXPERIMENTS WE CONDUCTED DID NOT INDICATE A PROBLEM WITH THE PRODUCT, AND REVIEWS OF THE INSPECTION AND VALIDATION DOCUMENTS DID NOT IDENTIFY ANY FAULTY MATERIALS OR EQUIPMENT, WE ARE UNABLE TO CLASSIFY THIS COMPLAINT AS A FAULTY PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A WARM PACK BURST WHEN A VISITOR ACTIVATED IT, SENDING THE CONTENTS INTO HIS EYES. HE WAS EVALUATED IN THE EMERGENCY ROOM AND DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WARM PACK, INSTANT, GEL, 6"X6" NONE IMD MEDLINE INDUSTRIES, INC. MDS139007 08231

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other