MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX BIVONA FLEXTEND¿ TTS¿ NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	67PFSS30
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Codes	Hypoxia (1918); Loss of consciousness (2418); Low Oxygen Saturation (2477)
Date of Event	10/05/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received that the cuff to a smiths medical portex bivona flextend¿ tts¿ pediatric tracheostomy tube was found to be asymmetrical.The patient was noted to be unresponsive, dusky in appearance with an oxygen saturation in the 40's.The patient was required to be manually bagged by the nurse and an emergent tracheostomy (trach) change out was required.Upon inspection of the removed trach, the cuff was not symmetrical with it being inflated more on one side.The patient recovered with no further adverse effects.

• Brand Name: PORTEX BIVONA FLEXTEND¿ TTS¿ NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7015351
• Report Number: 3012307300-2017-02389
• Device Sequence Number: 1410960
• Product Code: JOH
• UDI-Device Identifier: 10351688518675
• UDI-Public: 10351688518675
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Nurse
• Device Expiration Date: 06/07/2022
• Device Catalogue Number: 67PFSS30
• Device Lot Number: 3445411
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2017
• Initial Report FDA Received Date: 11/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: MW5072800
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention