MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA; CUSTOM 6.0 TTS HYPERFLEX

Model Number	HT14KS60NSC287S
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Two devices received for evaluation.Both device cuffs were inflated using air.Upon visual inspection, no fuzz was present in either cuff or inflation balloon.Both cuffs had teflon spray visible through the cuff.When the device is manufactured, the tts cuff is sprayed internally with a liquid teflon spray (ptfe release agent) to coat the inside of the cuff to prevent the silicone cuff from sticking to the shaft.Teflon spray appears foggy when looking through the clear cuff and allows it to inflate and deflate properly.Both cuffs inflated and deflated accordingly with no difficulties observed.The reported customer complaint was unable to be confirmed.
Event or Problem Description
Information was received that device had fuzz visible in cuff.Tracheostomy was used from march 3 to march 21.A tube change out occurred as a result, and the incident was then reported to be resolved.No adverse effects reported.

• Brand Name: BIVONA
• Common Device Name: CUSTOM 6.0 TTS HYPERFLEX
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• MDR Report Key: 10083643
• Report Number: 3012307300-2020-04920
• Device Sequence Number: 678517
• Product Code: JOH
• UDI-Device Identifier: 15019517022605
• UDI-Public: 15019517022605
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/22/2020

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: Health Professional
• Device Model Number: HT14KS60NSC287S
• Device Catalogue Number: HT14KS60NSC287S
• Device Lot Number: DS026124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2020
• Initial Report FDA Received Date: 05/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention