MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® BIVONA® CUSTOM 8.0 TTS¿ TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	CM1930N
Medical Device Problem Code	Hole In Material (1293)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer has not returned the device to the manufacturer for device evaluation.If the devices becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
Event or Problem Description
It was reported that a portex® bivona® custom 8.0 tts¿ tracheostomy tube had a small hole in the cuff.The hole was noticed after the ventilator alarmed during the night.The event occurred at the patient's home.No injury was reported.
Additional Manufacturer Narrative
One used portex® bivona® custom 8.0mm tracheostomy tube was returned for investigation.Functional testing was performed, and the cuff was unable to fully inflate and immediately deflated as air escaped from a small hole in the cuff.Upon visual inspection of the cuff, it was noted that there are tiny scratches next to the small hole on the cuff, perhaps caused by the device coming into contact with something sharp externally or potentially from hard cartilage internal to the patient.A review of the device history record was performed and no abnormalities were found.A root cause was unable to be determined.The complaint was confirmed.

• Brand Name: PORTEX® BIVONA® CUSTOM 8.0 TTS¿ TRACHEOSTOMY TUBE
• 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: 6530915
• Report Number: 3012307300-2017-00963
• Device Sequence Number: 12310
• Product Code: JOH
• UDI-Device Identifier: 15019517033427
• UDI-Public: 15019517033427
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2017

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: 12/19/2021
• Device Catalogue Number: CM1930N
• Device Lot Number: DS000859
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2017
• Supplement Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 04/28/2017
• Supplement Report FDA Received Date: 08/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1