FDA Adverse Event Malfunction Summary report: N

UMBILI-CATH

MDR report key: 6979584 · Received October 26, 2017

Report

Report Number: 1718873-2017-00001
Event Type: Malfunction
Date Received: October 26, 2017
Report Date: October 26, 2017
Manufacturer: UTAH MEDICAL PRODUCTS INC.
Product Code: FOS
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THESE TWO EVENTS ARE BEING REPORTED PER THE ASR REPORTING REQUIREMENTS UNDER EXEMPTION NUMBER 2011004. BOTH CATHETERS HAD EVIDENCE THAT THE CAUSE OF THE TUBING SEVER WAS RELATED TO THE APPLICATION OF AN EXCESSIVE TENSILE FORCE ON THE CATHETER TUBING. THE TUBING ON BOTH CATHETERS WAS TESTED FOR TENSILE FORCE. THE FORCE REQUIRED TO BREAK THE TUBING AND THE TUBING ELONGATION WERE WITHIN SPECIFICATION. ON CATHETER #1 SURGICAL INTERVENTION WAS USED TO REMOVE THE CATHETER. THERE WAS NO SIGNIFICANT BLOOD LOSS AS A RESULT OF THE TUBING SEVER. THERE WAS NO PERMANENT IMPAIRMENT TO A BODY FUNCTION OR DAMAGE TO A BODY STRUCTURE. ON CATHETER #2 THERE WAS NO SIGNIFICANT BLOOD LOSS. THE CATHETER WAS ROUTINELY REPLACED WITHOUT PATIENT IMPACT.

Description of Event or Problem · 1

THIS REPORT SUMMARIZES 2 REPORTED EVENTS. ON ONE OF THESE EVENTS THE TUBING WAS SEVERED WHILE THE CATHETER WAS BEING REMOVED FROM THE PATIENT. THE TUBING SEGMENT WHICH WAS SEVERED FROM THE CATHETER WAS REMOVED FROM THE PATIENT USING A SURGICAL PROCEDURE. THE PATIENT DID NOT LOSE ANY BLOOD AS RESULTS OF THE TUBING SEVER, AND THE NURSE REPORTING THE EVENT INDICATED THAT THIS WAS NOT AN ADVERSE EVENT. ON THE 2ND EVENT THE CATHETER TUBING WAS SEVERED JUST BELOW THE HUB AFTER ABOUT 5 HOURS USE. THE NICU CLINICAL COORDINATOR AT THE HOSPITAL STATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT AS A RESULT OF THE TUBING SEVER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
761556	UMBILI-CATH	UMBILICAL CATHETER	FOS	UTAH MEDICAL PRODUCTS INC.	N/A

Patients

Seq	Age	Sex	Outcome	Treatment
1