FDA Adverse Event Malfunction Summary report: N

BIVONA TTS TRACHEOSTOMY TUBES

MDR report key: 5846148 · Received August 4, 2016

Report

Report Number: 2183502-2016-01660
Event Type: Malfunction
Date Received: August 4, 2016
Date of Event: June 10, 2016
Report Date: July 7, 2016
Manufacturer: SMITHS MEDICAL ASD INC.
Product Code: JOH
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION. POSSIBLE LOT NUMBERS: 2844620 OR 2927315. (B)(4).

Additional Manufacturer Narrative · 1

THE REPORTED 8.5MM TTS¿ TRACHEOSTOMY TUBE WAS RETURNED FOR INVESTIGATION WITH 3 OTHER TRACHEOSTOMY TUBES. A REVIEW OF THE DEVICE HISTORY RECORD, RELEVANT TO THE REPORTED LOT, FOUND NO NON-CONFORMITIES OR ISSUES DURING MANUFACTURING. DURING FUNCTIONAL TESTING, THE DEVICE CUFF WAS INFLATED WITH 18CC OF AIR AND A LEAK WAS DETECTED. UPON EXAMINATION, A SMALL CUT WAS FOUND ON THE SIDE OF THE AIRWAY BALLOON. THE CUFF WAS THEN INFLATED WITH WATER AND WATER WAS OBSERVED ESCAPING FROM THE SMALL CUT ON THE SIDE OF THE AIRWAY BALLOON. INVESTIGATION WAS UNABLE TO DETERMINE THE ROOT CAUSE OF THE SMALL CUT; HOWEVER, NO EVIDENCE WAS FOUND TO SUGGEST AN INTRINSIC PRODUCT DEFECT. (B)(4).

Description of Event or Problem · 1

THIS EVENT OCCURRED IN (B)(6). THE CARE ASSESSOR REPORTED ON BEHALF OF THE PATIENT THAT THE BIVONA TTS TRACHEOSTOMY TUBE WAS LEAKING FROM THE BALLOON AFTER FILLING THE CUFF WITH WATER. THE TUBE ENDED UP GETTING CHANGED. THERE WAS NO REPORTED INFORMATION ON THE PATIENTS CONDITION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
500172	BIVONA TTS TRACHEOSTOMY TUBES	TUBE TRACHEOSTOMY AND TUBE CUFF	JOH	SMITHS MEDICAL ASD INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1	51 YR