MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX REINFORCED SOFT-SEAL TRACHEAL TUBE; TUBE, TRACHEAL (W/WO CONNECTOR)

Catalog Number	100/110/085
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that after 30 minutes use of a tracheal tube, air leakage was observed from the cuff.The faulty tube was exchanged with a new one.The tube was checked in according to the instructions for use.Post-use testing was done on the tube and the leak was confirmed by observing the inflated cuff placed in water.There was no patient injury associated with this incident.
Additional Manufacturer Narrative
One endotracheal tube was returned for evaluation.The returned sample was visually inspected and no discrepancies were observed.The returned device sample underwent leak testing by inflating and using a syringe.It was submerged under water, and a leak was observed.The most probable root cause is that the product became damaged after it left the shm facilities.This investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.

• Brand Name: PORTEX REINFORCED SOFT-SEAL TRACHEAL 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: 7764602
• Report Number: 3012307300-2018-03056
• Device Sequence Number: 1560363
• Product Code: BTR
• UDI-Device Identifier: 15019315050817
• UDI-Public: 15019315050817
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K032112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 100/110/085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2018
• Supplement Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 08/08/2018
• Supplement Report FDA Received Date: 11/01/2018
• 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: Other; Required Intervention