BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINER 3000CC FLEX ADVANTAGE

    MDR report key: 3234041 · Received July 18, 2013

    Report

    Report Number
    1423537-2013-00032
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 6, 2013
    Report Date
    July 18, 2013
    Manufacturer
    CARDINAL HEALTH
    Product Code
    GCX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT SAMPLE WAS RECEIVED AT THE (B)(4) FACILITY AFTER IRRADIATION STERILIZATION AT ANOTHER CARDINAL HEALTH FACILITY. A VISUAL INSPECTION OF THE RETURNED 3000CC FLEX UNIT WAS PERFORMED BY QUALITY AND ENGINEERING MANAGEMENT PERSONNEL. THE UNIT EXHIBITED DAMAGE INDICATIVE OF AN IMPLOSION EVENT WHERE THE INSIDE PORTION OF THE LID WAS TOTALLY SEPARATED FROM THE OUTER PORTION OF THE LID. THE LID REMNANT HELPED IDENTIFY THE LID CAVITY NUMBER AS '18A' AND LID DATE CODE OF 01-13. THE RETURNED UNIT WAS DIMENSIONALLY INSPECTED WITH A DIMENSIONAL SPECIFICATION OF 0.064¿ ¿ 0.065" THROUGHOUT THE LID REMNANT. THEREFORE, THE LID COMPONENT MET THE QUALITY SPECIFICATION FOR WALL THICKNESS (SPECIFICATION = 0.060" TO 0.080¿). DURING THE VISUAL EXAMINATION, THERE APPEARED TO BE PRODUCT DAMAGE TO THE INSIDE PORTION OF THE LID AND BASKET AREA. THIS DAMAGE COULD BE INDICATIVE OF SHIPPING DAMAGE. WITH THE INFORMATION AVAILABLE NO SPECIFIC ASSIGNABLE CAUSE CAN BE DETERMINED. ALTHOUGH NOT VERIFIABLE, THE 'AT CUSTOMER SITE' UNIT MAY HAVE RECEIVED PREVIOUS DAMAGE DURING PROCESSING, PACKOUT, OR SUBSEQUENT SHIPPING AND HANDLING INCLUDING AT THE CUSTOMER SITE PRIOR TO USE. A DAMAGED OR CRACKED LID WOULD NOT MEET THE REQUIREMENTS OF THE VACUUM STRESS ASSOCIATED WITH THE USE OF THE PRODUCT. WITHOUT A SPECIFIC ASSIGNABLE CAUSE BEING ESTABLISHED, NO SPECIFIC CORRECTIVE ACTION CAN BE DETERMINED. THE PRODUCT IS DESIGNED TO MEET IMPLOSION RESISTANCE REQUIREMENTS PER ISO 10079-3 "MEDICAL SUCTION EQUIPMENT - PART 3: SUCTION EQUIPMENT POWERED FROM VACUUM OR PRESSURE SOURCE". PRODUCTION AND KEY PERSONNEL HAVE BEEN MADE AWARE OF THIS CONCERN THROUGH THIS INVESTIGATIVE PROCESS. NO ADDITIONAL INVESTIGATION IS PLANNED AT THIS TIME. HOWEVER, WE WILL CONTINUE TO MONITOR CONCERNS SUCH AS THESE FOR POSSIBLE FUTURE ACTIONS.

    Description of Event or Problem · 1

    CANISTER IMPLODED AT BEGINNING OF THE CASE. LID IMPLODED INWARD. THERE WAS A VERY LOUD NOISE LIKE A GUNSHOT SOUND. THE DOCTOR SITTING NEXT TO IT HAD RINGING IN HIS EARS THE FIRST DAY AND AS OF FRIDAY HIS RIGHT EAR STILL FELT "FUZZY". HE WAS GOING TO WAIT TO SEE IF IT WENT AWAY AND POSSIBLY SEE ONE OF HIS PARTNERS FOR EVALUATION IF IT DID NOT. ADDITIONALLY, THE CUSTOMER STATED THE DOCTOR WAITED UNTIL (B)(6) 2013, BEFORE DECIDING TO GET A HEARING TEST. THE TEST REVEALED THERE WAS NO HEARING LOSS. THE DOCTOR REPORTED THE RINGING IN THE EAR HAS SUBSIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335158 LINER 3000CC FLEX ADVANTAGE SUCTION LINER GCX CARDINAL HEALTH 65651-930C NO LOT GIVEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other