PORTEX BIVONA CUFFLESS TRACHEAL TUBE

Report

Report Number: 3012307300-2019-02594
Event Type: Injury
Date Received: May 9, 2019
Date of Event: March 2, 2019
Report Date: June 24, 2019
Manufacturer: SMITHS MEDICAL ASD, INC.
Product Code: BTR
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

DEVICE EVALUATION: ONE SAMPLE WAS RECEIVED FROM P/N 60PFSS45 WITHOUT ITS ORIGINAL PACKAGING INSIDE A ZIPLOC BAG. SAMPLE WAS RECEIVED IN USED CONDITION WITH ITS CERTIFICATE OF DECONTAMINATION. VISUAL INSPECTION WAS PERFORMED TO DETECT ANY DAMAGE ON THE PARTS. A SPLIT WAS FOUND ON THE NECK FLANGE. ADDITIONAL, DURING THE VISUAL INSPECTION CONTAMINATION WAS OBSERVED ON THE UNIT AND IT WAS OBSERVED THAT SURFACE OF TUBE WAS WORN. PER PREVIOUS COMPLAINTS, A REVIEW OF THE MANUFACTURING PROCESS FOR P/N 60PFSS35 AND L/N 3802103, WAS CONDUCTED BY QUALITY ENGINEER ON 15/MAY/2019 IN ORDER TO VERIFY THAT THERE ARE NO SITUATIONS OR PRACTICES THAT COULD CREATE THE EVENT AS DESCRIBED IN "DESCRIPTION OF NON-CONFORMANCE" SECTION. ALL PROCEDURES ARE BEING CARRIED APPROPRIATE. AFTER A REVIEW OF THE DIFFERENT VERIFICATIONS THAT ARE PERFORMED DURING THE MANUFACTURING PROCESS TO DETECT DAMAGE COMPONENTS, THE MOST PROBABLE ROOT CAUSE IS THAT DAMAGED OCCURRED AFTER THE PRODUCT LEFT THE SHM FACILITY. CUSTOMER REPORTED CONDITION IS CONFIRMED.

Description of Event or Problem · 1

INFORMATION WAS RECEIVED THAT THE FLANGE A SMITHS MEDICAL PORTEX BIVONA CUFFLESS TRACHEAL TUBE BROKE DURING A ROUTINE TRACH CHANGE PERFORMED BY STAFF NURSE. NURSE THEN BEGAN REPLACED THE TRACH WITH BACK UP TRACH. PATIENT WAS STABLE DURING THE ENTIRE PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
387441	PORTEX BIVONA CUFFLESS TRACHEAL TUBE	TUBE, TRACHEAL (W/WO CONNECTOR) PRODUCT CODE: BTR	BTR	SMITHS MEDICAL ASD, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1	11 MO		Required Intervention