BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOGARTY - HYDRAGRIP SURGICAL - CLAMP INSERTS

    MDR report key: 3269714 · Received August 7, 2013

    Report

    Report Number
    2015691-2013-20747
    Event Type
    Malfunction
    Date Received
    August 7, 2013
    Date of Event
    July 8, 2013
    Report Date
    July 12, 2013
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DXC
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES ARE EXPECTED TO BE RETURNED FOR EVALUATION; HOWEVER, IT HAS NOT YET BEEN RECEIVED. THIS REPORT IS ASSOCIATED WITH REPORT # 201569-2013-20746.

    Additional Manufacturer Narrative · 1

    ONE SET OF HYDRA61 INSERTS IN OPENED ORIGINAL PACKAGING WERE RETURNED FOR EVALUATION. THE POUCH EDGES OF THE PACKAGING WERE CLOSED WITH TAPE AND THE TAPE WAS CAREFULLY REMOVED PRIOR TO EVALUATION. THE REPORTED CUSTOMER COMPLAINT OF CONTAMINATION ISSUE WAS CONFIRMED. FOUR WHITE PARTICLES, APPROXIMATELY 0.01", 0.02", 0.03", AND 0.04" IN LENGTH, WERE OBSERVED INSIDE THE POUCH DURING EVALUATION. THIS EXCEEDS THE ACCEPTABLE NUMBER OF SHARDS PER SPECIFICATION (MAXIMUM OF TWO FIBERS OR TRIM SHARDS THAT ARE LESS THAN OR EQUAL TO 0.25" IN LENGTH). CHEMISTRY TESTING FOUND THE SUBSTANCE SHOWED SIMILAR ABSORPTION CHARACTERISTICS WHEN COMPARED TO POLYCARBONATE AND POLYISOPRENE LIKE MATERIALS. THERE WAS NO VISIBLE DAMAGE FOUND ON THE TYVEK OR THE POUCH. VISUAL EXAMINATION WAS PERFORMED UNDER MICROSCOPE AT 10X TO 40X MAGNIFICATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT THE DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. AN INVESTIGATION HAS BEEN INITIATED TO CONSIDER ANY POTENTIAL MANUFACTURING FACTORS THAT MAY HAVE CONTRIBUTED TO THIS COMPLAINT.

    Additional Manufacturer Narrative · 1

    THE REPORTED CUSTOMER COMPLAINT OF CONTAMINATION ISSUE WAS CONFIRMED. THE SPECIFICATION USED IN THE PROCEDURE FOR TESTING OF PARTICULATE MATTER HAS BEEN UPDATED TO INCLUDE THAT THERE SHOULD BE ¿NO VISIBLE LOOSE PARTICULATE MATTER OR FIBER PRESENT AT 2.5X MAGNIFICATION VISUAL INSPECTION¿. EVALUATION DID CONFIRM FOUR WHITE PARTICLES INSIDE THE POUCH; APPROXIMATELY 0.01", 0.02", 0.03", AND 0.04" IN LENGTH. ADDITIONAL VISUAL EXAMINATION CONFIRMED ALL PARTICULATES WERE LOOSE INSIDE THE POUCH, EXCEEDING SPECIFICATIONS. AN INVESTIGATION HAS BEEN INITIATED TO CONSIDER ANY POTENTIAL MANUFACTURING FACTORS THAT MAY HAVE CONTRIBUTED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "UNKNOWN WHITE POWDER¿ LIKE MATERIAL WAS FOUND IN THE POUCH WHEN THE CUSTOMER OPENED IT BEFORE USE. ANOTHER POUCH FROM THE DIFFERENT LOT NUMBER WAS OPENED BUT THE SAME ¿WHITE POWDER¿ LIKE MATERIAL WAS OBSERVED IN THE POUCH. IT WAS INDICATED THAT THE CUSTOMER FELT THAT THERE SEEMED TO BE NO PROBLEM WITH THE INSERT ITSELF, AND THE INSERT FROM THE LAST OPENED POUCH WAS USED. THERE WERE NO PROBLEMS NOTED DURING USE. IT WAS FURTHER STATED THAT THE MOST OF THE MATERIAL FELL OFF AND WAS LOST AT THE HOSPITAL; HOWEVER, SOME COULD STILL BE IDENTIFIED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370101 FOGARTY - HYDRAGRIP SURGICAL - CLAMP INSERTS CLAMP, VASCULAR DXC EDWARDS LIFESCIENCES, PR HYDRA61 59361130

    Patients

    Seq Age Sex Outcome Treatment
    1