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

Catalog Number	HT14DS70NSC148S
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that a cuff to a smiths medical portex bivona flextend¿ tts¿ tracheostomy tube would not inflate during pre-use check.There were no reported adverse effects.
Additional Manufacturer Narrative
Two customized hyperflex tracheostomy tubes were received for analysis.No visual defects were noted upon visual examination.A 10ml syringe was used to insert air into bother the inflation lines; revealing that the cuff remained stuck to the shaft.The instructions for use (ifu) was reviewed and attempted inflating the cuff (attach a syringe to the pilot balloon and slowly test inflate the cuff with 5ml of sterile water for pediatrics cuffs (2.5-6.0mm) and 10ml of sterile water for adult cuffs (6.5-9.5mm).If the cuff does not inflate completely, squeeze the pilot balloon while gently manipulating the cuff from the shaft).Following the instructions, both cuffs released from the shafts.The devices were deflated and inflated two additional times over a four day period with the cuff resting in its deflated state; no additional sticking of the cuffs.No manufacturing defect was identified in the investigation.Based on the investigation, the allegation is confirmed.However, no fault was found for the root cause.

• Brand Name: PORTEX BIVONA FLEXTEND¿ TTS¿ TRACHEOSTOMY TUBES
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 7764659
• Report Number: 3012307300-2018-03108
• Device Sequence Number: 1757161
• Product Code: JOH
• UDI-Device Identifier: 10351688765727
• UDI-Public: 10351688765727
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 10/27/2022
• Device Catalogue Number: HT14DS70NSC148S
• Device Lot Number: DS010083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2018
• Supplement Date Received by Manufacturer: 08/31/2018
• Initial Report FDA Received Date: 08/08/2018
• Supplement Report FDA Received Date: 09/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1