FDA Adverse Event Malfunction Summary report: N

KANGAROO

MDR report key: 20464464 · Received October 16, 2024

Report

Report Number: 1423537-2024-00244
Event Type: Malfunction
Date Received: October 16, 2024
Date of Event: January 22, 2024
Report Date: October 16, 2024
Manufacturer: CARDINAL HEALTH 200, LLC
Product Code: KNT
UDI-DI: 10192253007855
PMA / PMN Number: SEE H10
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

510(K)NUMBERS: K163002 AND K12355. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE THE SERIAL NUMBER WAS NOT RECEIVED WITH THE COMPLAINT. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO THE RELEASE OF PRODUCT. ONE PHYSICAL SAMPLE WAS RECEIVED BY CARDINAL HEALTH BUT ONLY A PHOTO WAS PROVIDED TO THE SUPPLIER PER THEIR REQUEST. PER THE SUPPLIER, THE PROVIDED PHOTO WAS REVIEWED, AND THE REPORTED CONDITION WAS CONFIRMED. BASED ON ALL AVAILABLE INFORMATION, THE ROOT CAUSE COULD NOT BE DETERMINED. A CORRECTIVE ACTION IS NOT APPLICABLE AT THIS TIME. FUNCTIONAL TESTING AND VISUAL INSPECTIONS ARE BEING PERFORMED ACCORDING TO CURRENT QUALITY STANDARDS AND INSPECTION PROCEDURES. ALL INFORMATION RECEIVED WILL BE USED FOR FURTHER TRACKING AND TRENDING PURPOSES.

Description of Event or Problem · 0

THE CUSTOMER REPORTED THAT DOBHOFF TUBE RUPTURED LONGITUDINALLY APPROXIMATE 2 CM IN LENGTH. ENTERAL FEEDS WERE REFLUXING OUT OF THE PATIENT'S LEFT NARE. PER CUSTOMER, THE TUBE WAS REMOVED AND REPLACED. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WAS NO MEDICAL INTERVENTION OR TREATMENT PROVIDED. THE PATIENT IS DOING OK.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1321010	KANGAROO	TUBES, GASTROINTESTINAL (AND ACCESSORIES)	KNT	CARDINAL HEALTH 200, LLC	461055E		10192253007855

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown