MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® ULTRAPERC® SINGLE STAGE DILATOR; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	100/591/080
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	01/31/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received that a smiths medical tracheostomy was tested prior to use and no leakage noted.However, upon use, the patient's vital signs began dropping, oxygen saturation was decreasing.Device was removed and replacement tube was used.A leak in the balloon was noted.
Additional Manufacturer Narrative
Device evaluation: two (2) blue line ultra tracheostomy tubes, p/n 007/911/680 l/n 3567566; were received in used condition without their original packaging.Visual inspection was performed and no discrepancies were found.Functional testing was performed with a syringe used to inflate the cuff of the samples and then they were submerged under water in order to verify for leaks.One sample leaked at the cuff, the other sample could not be inflated due to a strange substance that did not allow air to enter.The customer reported condition was confirmed.Probable cause is unknown.

• Brand Name: PORTEX® ULTRAPERC® SINGLE STAGE DILATOR
• 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: 8480104
• Report Number: 3012307300-2019-01748
• Device Sequence Number: 16457183
• Product Code: JOH
• UDI-Device Identifier: 15019315048326
• UDI-Public: 15019315048326
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K041348
• 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,Followup
• Report Date (Section B): 06/12/2019

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: No Information
• Device Catalogue Number: 100/591/080
• Device Lot Number: 3620738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 04/03/2019
• Supplement Report FDA Received Date: 06/12/2019
• 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