FDA Adverse Event Malfunction Summary report: N

KANGAROO

MDR report key: 21976559 · Received May 7, 2025

Report

Report Number: 1423537-2025-00191
Event Type: Malfunction
Date Received: May 7, 2025
Date of Event: April 18, 2025
Report Date: May 7, 2025
Manufacturer: CARDINAL HEALTH 200, LLC
Product Code: KNT
UDI-DI: 10192253011524
PMA / PMN Number: K180622
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

ADDITIONAL PRODUCT CODE: PIF. ADDITIONAL 510K: K932295. A NON-CONFORMANCE REVIEW COULD NOT BE PERFORMED BECAUSE NO LOT INFORMATION WAS PROVIDED WITHIN THE COMPLAINT. PRIOR TO A LOT¿S RELEASE, THE LOT MUST BE DEEMED ACCEPTABLE BY-PASSING INSPECTIONS THAT ARE BASED ON A VALID SAMPLING PLAN. DURING PRODUCTION, INSPECTORS ROUTINELY EXAMINE A STATISTICAL SAMPLE BOTH PHYSICALLY AND VISUALLY. THERE WERE NO DEVICES RETURNED FOR EVALUATION; THEREFORE, THE AFFECTED PRODUCTS COULD NOT BE EVALUATED TO CONFIRM THE REPORTED FAILURE MODE. AS SUCH, A ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR RELATED REPORTS TO DETERMINE IF ADDITIONAL ACTIONS ARE NECESSARY.

Description of Event or Problem · 0

THE CUSTOMER REPORTED THEY HAVE FOUND SOME ISSUES WITH G-TUBES THEY HAVE IN STOCK. THERE'S A LADY FROM THE NURSING HOME WHO HAD ONE REPLACED LAST WEEK AND IT CAME OUT. AND THEY SAW AN EMERGE YESTERDAY AND THE BALLOON WAS DEFECTIVE AND POPPED. THEY THEN INSERTED ANOTHER ONE AND FILLED THE BALLOON AND IMMEDIATELY IT POPPED AGAIN. THEY INSPECTED IT AND IT WAS THE BALLOON THAT WAS DEFECTIVE. THEY PLACED ANOTHER ONE BUT THEY ARE NOT SURE HOW DURABLE IT IS GOING TO BE. NO FURTHER INFORMATION WILL BE PROVIDED BY THE CUSTOMER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1819615	KANGAROO	TUBES, GASTROINTESTINAL (AND ACCESSORIES)	KNT	CARDINAL HEALTH 200, LLC	8884720205		10192253011524

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown