BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREY-ALZATE-COONS DOUBLE LUMEN GASTROJEJUNOSTOMY SET

    MDR report key: 4213166 · Received September 25, 2014

    Report

    Report Number
    1820334-2014-00482
    Event Type
    Malfunction
    Date Received
    September 25, 2014
    Report Date
    September 5, 2014
    Manufacturer
    COOK INC
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    A REVIEW OF INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL, TRENDS, AND A VISUAL INSPECTION OF THE RETURNED DEVICE WERE CONDUCTED DURING THE INVESTIGATION. ONE USED AND DAMAGED DOUBLE LUMEN GASTROJEJUNOSTOMY (GJS) CATHETER WAS RETURNED FOR INVESTIGATION. INSPECTION OF THE DEVICE REVEALED THAT THE DEVICE HAD RUPTURED AT THE DISTAL BOND. A 0.045" WIRE GUIDE WAS PUSHED THROUGH THE DISTAL TIP OF THE DEVICE TOWARDS THE RUPTURED AREA. EXTREME RESISTANCE WAS FELT WHILE ADVANCING THE WIRE GUIDE. THE WIRE SHOULD HAVE MOVED WITH EASE THROUGH THE DEVICE AS THE END HOLE OF THE DEVICE IS 0.072. UPON ADVANCING THE WIRE THROUGH THE RUPTURED LUMEN TOWARDS THE DISTAL TIP OF THE DEVICE, A LIGHT BROWN THICKENED SUBSTANCE WAS PUSHED OUT OF THE CATHETER. UPON REMOVING THE WIRE GUIDE, THE SAME SUBSTANCE COATED THE WIRE. THE DISTAL TIP OF THE DEVICE APPEARED TO BE MISSING. THE DEVICE IS SUPPLIED WITH INSTRUCTIONS FOR USE PAMPHLET, WHICH DESCRIBES THE APPROPRIATE WARNINGS, PRECAUTIONS, AND PLACEMENT TECHNIQUES. IT IS LIKELY THAT THE DEVICE BECAME OCCLUDED WITH A FEEDING SUBSTANCE WHICH CAUSED EXCESS PRESSURE AT THE DISTAL BOND, ULTIMATELY RESULTING IN THE RUPTURE OF THE DEVICE. WE HAVE NOTIFIED APPROPRIATE INTERNAL PERSONNEL AND WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

    NO PATIENT INJURY WAS REPORTED. HOLE IN THE DEVICE IS NOT LABELED IN THE IFU. INVESTIGATION- A REVIEW OF INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL, TRENDS, AND A VISUAL INSPECTION OF THE RETURNED DEVICE WERE CONDUCTED DURING THE INVESTIGATION. ONE USED AND DAMAGED DOUBLE LUMEN GASTROJEJUNOSTOMY (GJS) CATHETER WAS RETURNED FOR INVESTIGATION. INSPECTION OF THE DEVICE REVEALED THAT THE DEVICE HAD RUPTURED AT THE DISTAL BOND. A 0.045" WIRE GUIDE WAS PUSHED THROUGH THE DISTAL TIP OF THE DEVICE TOWARDS THE RUPTURED AREA. EXTREME RESISTANCE WAS FELT WHILE ADVANCING THE WIRE GUIDE. THE WIRE SHOULD HAVE MOVED WITH EASE THROUGH THE DEVICE AS THE END HOLE OF THE DEVICE IS 0.072. UPON ADVANCING THE WIRE THROUGH THE RUPTURED LUMEN TOWARDS THE DISTAL TIP OF THE DEVICE, A LIGHT BROWN THICKENED SUBSTANCE WAS PUSHED OUT OF THE CATHETER. UPON REMOVING THE WIRE GUIDE, THE SAME SUBSTANCE COATED THE WIRE. THE DISTAL TIP OF THE DEVICE APPEARED TO BE MISSING. THE DEVICE IS SUPPLIED WITH INSTRUCTIONS FOR USE PAMPHLET, WHICH DESCRIBES THE APPROPRIATE WARNINGS, PRECAUTIONS, AND PLACEMENT TECHNIQUES. IT IS LIKELY THAT THE DEVICE BECAME OCCLUDED WITH A FEEDING SUBSTANCE WHICH CAUSED EXCESS PRESSURE AT THE DISTAL BOND, ULTIMATELY RESULTING IN THE RUPTURE OF THE DEVICE. THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. THE ROOT CAUSE APPEARS TO BE RELATED TO THE PRODUCT RECEIVING EXCESSIVE PRESSURE DURING USE. WE HAVE NOTIFIED APPROPRIATE INTERNAL PERSONNEL AND WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    A HOLE IS OCCURRING IN THE TUBE INSIDE OF THE PATIENT. THIS IS EITHER THE 3RD OR 4TH OCCURRENCE OF THIS PROBLEM WITH THE SAME PATIENT. THE PATIENT IS BEING TAKEN CARE OF BY NURSES IN HIS HOME. HE HAS HIS OWN STAFF. THE PATIENT DID REQUIRE ADDITIONAL GJ TUBE PLACEMENT PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 1

    A HOLE IS OCCURRING IN THE TUBE INSIDE OF THE PT. THIS IS EITHER THE 3RD OR 4TH OCCURRENCE OF THIS PROBLEM WITH THE SAME PT. THE PT IS BEING TAKE CARE OF BY NURSES IN HIS HOME. HE HAS HIS OWN STAFF. THE PT DID REQUIRE ADDITIONAL GJ TUBE PLACEMENT PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599406 CAREY-ALZATE-COONS DOUBLE LUMEN GASTROJEJUNOSTOMY SET KNT TUBES, GASTROINTESTINAL KNT COOK INC N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK