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

Model Number	100/110/065
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/23/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that a smiths medical endotracheal tube was leaking; the inflation line and tube was noted to have been partially torn.No patient injury occurred.
Event or Problem Description
Investigation results completed on a smiths medical intubation|portex endotracheal tubes.Summary of analysis on h 10.
Additional Manufacturer Narrative
Investigation results completed on a smiths medical intubation|portex endotracheal tubes.The complaint of cuff had leaking and torn around line was confirmed.Investigation looked at description of non-conformance audit.No discrepancies were detected thirty-two units.The complaint is verified and root cause to most probable t probable root causes are: lack of solvent in the insertion of the inflation line to tub lack of detection by production personnel.Action taken to retrain production personal.Re training to manufacturing personnel in the procedure mp rtt tj rev 101 - reinforced tracheal tube bell out, fit inflation line, inflate cuff & pressure decay test by the quality engineer on 13/jan/2020 to reinforce the op 2.4 where states the correct way to applied solvent to the inflation line.

• Brand Name: SMITHS MEDICAL PORTEX ENDOTRACHEAL TUBE
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane n; minneapolis MN 55442
• MDR Report Key: 9404190
• Report Number: 3012307300-2019-06296
• Device Sequence Number: 11320460
• Product Code: BTR
• UDI-Device Identifier: 15019315050770
• UDI-Public: 15019315050770
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2020

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: 11/26/2023
• Device Model Number: 100/110/065
• Device Catalogue Number: 100/110/065
• Device Lot Number: 3738873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2019
• Supplement Date Received by Manufacturer: 11/14/2019
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 02/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1