FDA Adverse Event Malfunction Summary report: N

MOSS GASTROSTOMY TUBE

MDR report key: 10459212 · Received August 27, 2020

Report

Report Number
10459212
Event Type
Malfunction
Date Received
August 27, 2020
Date of Event
August 14, 2020
Report Date
August 24, 2020
Manufacturer
MOSS TUBES, INC.
Product Code
KNT
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MN
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

PATIENT HAD NEW TYPE ENFIT FEEDING TUBE. (THE TRANSITION FROM PREVIOUS MANUFACTURER'S TUBES TO MOSS GJ TUBES HAS BEEN PLANNED FOR LATE 2020. SURGERY INSERTED A MOSS GJ TUBE IN PATIENT AS THIS PRODUCT IS ALREADY STOCKED ON THEIR CASE CARTS.) TUBE FEEDING AND (CRUSHED &/OR LIQUID) MEDICATIONS WERE TO BE GIVEN THROUGH THE THIRD LUMEN WITH SPECIAL FIT BD 3 CC SYRINGES. THERE WAS NOT EXCESSIVE FORCE USED TO GIVE MEDICATIONS PUSH THROUGH THIS LUMEN. A "POP" WAS HEARD & LEAKING WAS NOTED. THIS LUMEN WAS TAPED & CAPPED. AFTER CONSULT WITH AN MD & WITH ANOTHER (BARIATRIC) RN, IT WAS DECIDED OKAY TO USE MIDDLE LUMEN FOR TUBE FEEDING & MEDICATIONS. THIS WAS DONE WITH NO FURTHER LEAKING, & MEDS & FEEDING PROCEEDED WITHOUT PROBLEM. PRIMARY MD/SURGEON WAS UPDATED. THE NEXT DAY WRITER AND PRIMARY MD/SURGEON LOOKED AT THIS TOGETHER AND THE THIRD CAPPED LUMEN WAS NOTED TO BE LEAKING. MD ADVISED TO KEEP IT COVERED WITH ABSORBENT GAUZE & TO CHANGE Q2H OR PRN TO KEEP SITE AS DRY AS POSSIBLE. FOLLOW UP TO EVENT: NURSE MANAGER TALKED WITH RN CARING FOR PATIENT AND ASSESSED TUBE FEEDING SITE. MINIMAL DRAINAGE NOTED AT 3RD LUMEN. MANAGER OF EDUCATION AND CNS WERE MADE AWARE OF ENFIT PRODUCT BEING USED PRIOR TO IMPLEMENTATION AT THIS FACILITY WITH EDUCATION. CONNECTION ISSUE: MOSS HAD CHANGED CONNECTION TO ENFIT AND THIS FACILITY WAS NOT AWARE THAT THIS CHANGE HAD OCCURRED. PURCHASING DEPARTMENT IS WORKING ON OBTAINING ENFIT-COMPATIBLE SYRINGE TO HAVE IN STOCK TO USE IF ENFIT BEING USED PRIOR TO LAUNCH, INCLUDING PLACEMENT BY SURGEONS IN OUR OPERATING ROOM OR PLACED IN THE COMMUNITY. WE PRESENTLY DO NOT HAVE ANY ENFIT COMPATIBLE SYRINGES IN STOCK AT THIS FACILITY, BUT ARE IN THE PROCESS OF OBTAINING SYRINGES FOR ENFIT CONNECTIONS. THERE WAS NO HARM TO THE PATIENT THAT RESULTED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
922722 MOSS GASTROSTOMY TUBE TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT MOSS TUBES, INC. 5-17719

Patients

Seq Age Sex Outcome Treatment
1 26645 DA