FDA Adverse Event Malfunction Summary report: N

CORTRAK 2 EAS ELECTROMAGNETIC TRANSMITTING STYLET AND CORFLO FEEDING TUBE

MDR report key: 18747505 · Received February 21, 2024

Report

Report Number
18747505
Event Type
Malfunction
Date Received
February 21, 2024
Date of Event
January 1, 2024
Report Date
January 12, 2024
Manufacturer
CORPAK MEDSYSTEMS, INC.
Product Code
KNT
Product Problem
Yes
Report Source
User Facility report
Reporter Location
CA
Reporter Occupation
BIOMEDICAL ENGINEER
Health Professional
Yes

Narratives

Description of Event or Problem · 0

NASOGASTRIC / NASOINTESINAL FEEDING TUBE (NG TUBE) FRACTURED WITH A PIECE RETAINED IN THE BOWEL OF THE PATIENT. THE NG TUBE IS UNABLE TO BE SAFELY REMOVED GIVEN PATIENT'S PULMONARY HYPERTENSION (HTN), RECURRENT ATRIAL FIBRILLATION (A-FIB) WITH RAPID VENTRICULAR RESPONSE (RVR) WITH WORSENING SHOCK, HIGH ASPIRATION RISK. THE NG TUBE APPEARS TO HAVE BEEN PLACED ON [DATE REDACTED]. THERE IS A KIDNEY, URETER, AND BLADDER (KUB) X-RAY ON [DATE REDACTED] WHERE THE TUBE APPEARS INTACT. CHEST X-RAY (CXR) [DATE REDACTED] ALSO AVAILABLE WITH POSSIBLE DAMAGE BUT HARD TO DISTINGUISH, A KUB DID OCCUR AT THE SAME TIME BUT THE IMAGING CAPTURED IS LOW. CXR ALSO AVAILABLE. [DATE REDACTED] CXR IS THE FIRST IMAGE THAT SHOWS A CLEAR SEPARATION OF THE UPPER HALF AND LOWER HALF OF THE FEEDING TUBE. [DATE REDACTED] KUB CONFIRMS THIS WITH A RADIOLOGY READ. THE UPPER HALF OF THE TUBE WAS REMOVED ON [DATE REDACTED]. ADDITIONAL INFORMATION: UPON CHART REVIEW THE PATIENT REMAINED ON CONTINUOUS FEEDS THROUGH THIS DEVICE WITH THE INTERRUPTIONS/SIGNIFICANT EVENTS BEING THE FOLLOWING:[DATE REDACTED] - FEEDING TUBE CLOGGED, RESUMED 30 MINUTES LATER[DATE REDACTED] - STOPPED, COMMENT "FEEDING TUBE DISLODGED" SECUREMENT CHANGE CHARTED[DATE REDACTED] - STOPPED, COMMENT "FEEDING TUBE DISLODGEMENT" SECUREMENT CHANGED TO NASAL BRIDLEEVENTS REVIEWED WITH STAFF CARING FOR PATIENT PRIOR TO TUBE RUPTURE. THEY USED ESTABLISHED PRACTICES TO UNCLOG THE FEED TUBE, AVANOS CLOG ZAPPER REF #20-002 AND RECALL NO NEED FOR EXCESSIVE PRESSURE TO ACHIEVE PATENCY OF LINE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
62083 CORTRAK 2 EAS ELECTROMAGNETIC TRANSMITTING STYLET AND CORFLO FEEDING TUBE TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CORPAK MEDSYSTEMS, INC. 40-9431TRAK2

Patients

Seq Age Sex Outcome Treatment
1 80 YR Female