BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL

    MDR report key: 3983276 · Received July 3, 2014

    Report

    Report Number
    1037905-2014-00272
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 5, 2014
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    KNT
    PMA / PMN Number
    K920703
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVAL: A PRODUCT EVAL WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVAL. THE REPORT COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION CONCLUSIONS: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVAL. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. THE INSTRUCTIONS FOR USE STATES TO "SECURE THE TWIST LOCK OR CABLE TIE AROUND THE BOLSTER COLLAR, BEING CAREFUL NOT TO CRIMP IT. IMPORTANT: USE THE TWIST LOCK OR CABLE TIE TO SECURE THE BOLSTER TO THE TUBE. THIS WILL HELP PREVENT FUTURE MIGRATION OF THE TUBE AND REDUCE THE NEED TO CONSTANTLY REPOSITION OR PULL ON THE TUBE." THE INSTRUCTIONS FOR USE WARNS, "POTENTIAL COMPLICATIONS: TUBE DISLODGEMENT OR MIGRATION." PRIOR TO DISTRIBUTION, ALL FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED AND THIS REPRESENTS AN ISOLATED OCCURRENCE. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULT AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.

    Description of Event or Problem · 1

    A COOK FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL WAS PLACED IN THE PT. THE USER FACILITY REPORTED THE PT CAME BACK INTO THE OFFICE THE DAY AFTER TUBE PLACEMENT BECAUSE OF PAIN. THE PT THOUGHT THE EXTERNAL BOLSTER WAS TOO TIGHT. THE REPORTER WAS SURPRISED TO SEE THE MARKING WERE EVERY 2 CM ON THIS TUBE AND THE LARGE EXTERNAL BOLSTER HAD COVERED UP THE MARKING IT WAS SUPPOSED TO BE. THEY HAD NO GAUGE IF THE TUBE HAD MIGRATED OR NOT. THE REPORTER INDICATED THE PT WAS COMPLETELY CONFUSED AS HE SAW NO NUMBERS AT ALL. WHEN THE REPORTER ATTEMPTED TO EXTEND THE BOLSTER IT SIMPLY SLIPPED ALL THE WAY TO THE END WITH LITTLE RESISTANCE, THE SAME WITH TIGHTENING IT UP. THE REPORTER INDICATED THEY COULD SEE THE BOLSTER MOVING FOR THE PT. THE EXTERNAL BOLSTER HAD MIGRATED UP THE TUBE ALLOWING TUBE TO MOVE TOO FREELY CAUSING DISCOMFORT AND PAIN. THE FEEDING TUBE IS STILL BEING USED IN THE PT. OTHER THAN THE FEEDING TUBE ALREADY PLACED IN THE PT, A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADD'L PROCEDURE DUE TO THIS OCCURRENCE. ACCORDING TO THE REPORTER, OTHER THAN THE REPORTED PAIN AND DISCOMFORT AT THE TUBE SITE, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391997 FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL KNT WILSON-COOK MEDICAL INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1