MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX ENDOTRACHEAL TUBE; TUBE, TRACHEAL (W/WO CONNECTOR), PRODUCT CODE: BTR

Model Number	100/133/075
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report source: (b)(6).
Event or Problem Description
Information was received that at the time of anesthesia a smiths medical portex endotracheal tube had a balloon punctured and needed to be replaced.No adverse patient effects were reported.
Additional Manufacturer Narrative
One picture of the affected portex endotracheal tube was returned for analysis.Relevant documents were reviewed and deemed adequate.An audit of the production floor was conducted.Training records, bell out, fit inflation line, inflate cuff and pressure decay test operations were performed; no discrepancies.The bell-out, fit inflation line and pressure decay test operations were audited on 32 units; no discrepancies.Based on the evidence, the complaint was confirmed.However, the root cause is unknown.

• Brand Name: PORTEX ENDOTRACHEAL TUBE
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR), PRODUCT CODE: BTR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9685073
• Report Number: 3012307300-2020-00953
• Device Sequence Number: 3675632
• Product Code: BTR
• UDI-Device Identifier: 15019315020360
• UDI-Public: 15019315020360
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K931735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2020

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: No Information
• Device Expiration Date: 02/09/2023
• Device Model Number: 100/133/075
• Device Catalogue Number: 100/133/075
• Device Lot Number: 3567228
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2020
• Supplement Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 02/09/2020
• Supplement Report FDA Received Date: 05/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1