MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX BIVONA SMALL DIAMETER TTS AIRE-CUF ORAL/NASAL WIRE REINFORCED TUBE; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	35W040
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign: germany.
Event or Problem Description
Information was received that a smiths medical portex bivona small diameter tts aire-cuf oral/nasal wire reinforced tube (silicone) cuff would not inflate.No adverse effects were reported.
Additional Manufacturer Narrative
One endotracheal tube was returned for evaluation.The sample underwent functional testing to detect for leakage.Cuff was unable to be inflated with 5cc of air as it was stuck to the shaft.Cuff was then manipulated and was able to be inflated.The device was noted to be functioning as required, meeting criteria in manufacturing process.The reported customer complaint has not been confirmed.

• Brand Name: PORTEX BIVONA SMALL DIAMETER TTS AIRE-CUF ORAL/NASAL WIRE REINFORCED TUBE
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8733175
• Report Number: 3012307300-2019-02724
• Device Sequence Number: 2573257
• Product Code: BTR
• UDI-Device Identifier: 15021312014303
• UDI-Public: 15021312014303
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K792035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2019

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: 03/14/2023
• Device Model Number: 35W040
• Device Catalogue Number: 35W040
• Device Lot Number: 3582734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2019
• Supplement Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 08/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1