FDA Adverse Event Malfunction Summary report: N

PORTEX

MDR report key: 10879636 · Received November 20, 2020

Report

Report Number: 3012307300-2020-11655
Event Type: Malfunction
Date Received: November 20, 2020
Date of Event: October 22, 2020
Report Date: January 5, 2021
Manufacturer: SMITHS MEDICAL INTERNATIONAL, LTD.
Product Code: BTO
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

INVESTIGATION COMPLETED ON A SMITHS MEDICAL TRACHEOSTOMY/PVC - PORTEX TUBES BLUE LINE ULTRA (BLU). RECEIVED THREE PICTURES AND THE SMJ. THROUGH THE PICTURES, THIS REVEALED SMALL TEAR IN THE PILOT BALLOON. THEY WERE TESTED BY SAMPLES PN: 100/860/780. VISUALLY INSPECTED REVEALING SMALL TEAR IN THE PILOT BALLOON, NO DISCREPANCIES FOUND IN RETURNED SAMPLE. FUNCTIONAL TESTING WITH CUFF AND PILOT BALLOON OF THE RETURNED SAMPLE WERE INFLATED USING A SYRINGE WITH AIR, THEN THE PRODUCT WAS IMMERSED IN THE WATER IN ORDER TO DETECT ANY LEAKAGE WITH NO AIR BUBBLES REVEALED TO CONFIRM EVENT. THEN THE ENGINEERING WAS REVIEWED WITH PRODUCT PERFORMING AND INSPECTED 100% PRIOR TO RELEASE. THEORY OF CAUSE WAS PRODUCT MALFUNCTION OCCURRED AFTER LEAVING SMITHS MEDICAL. THE INSTRUCTION SAY ? GUARD AGAINST CUFF DAMAGE BY AVOIDING CONTACT WITH SHARP EDGES." NO FAULT WAS FOUND AND EVENT WAS NOT VALIDATED.

Description of Event or Problem · 0

INVESTIGATION COMPLETED AND SUMMARIZED IN H 10.

Additional Manufacturer Narrative · 1

THE LOT NUMBER IS UNKNOWN.

Description of Event or Problem · 1

INFORMATION WAS RECEIVED INDICATING THAT THE CUSTOMER NOTED AIR WAS LEAKING FROM THE CUFF OF THE PORTEX TUBES BLUE LINE ULTRA DURING USE. THERE WERE NO PATIENT INJURIES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1339668	PORTEX	TUBE, TRACHEAL (W/WO CONNECTOR)	BTO	SMITHS MEDICAL INTERNATIONAL, LTD.	100/860/070

Patients

Seq	Age	Sex	Outcome	Treatment
1