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

Model Number	100/166/070
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/11/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received indicating that immediately after placement of a smiths medical portex® endotracheal tube into a patient, the cuff was observed to deflate.The product was removed and returned for analysis.There were no reported adverse effects.
Event or Problem Description
Information was received that the tube was changed out as a result.This incident is now a serious injury as this constitutes medical intervention.
Additional Manufacturer Narrative
B5: additional information.One endotracheal tube was returned for evaluation.Visual inspection of the device found it to be in good physical condition.The cuff of the returned sample was inflated using a syringe and the product was submerged under water in order to detect any leakage; leak was observed coming out from the seal of the cuff.The cuff seal operation was audited during 32 units, in order to verify that the operation was properly performed and to visually inspect the cuff for incomplete seal.No discrepancies were detected.The reported customer complaint has been confirmed, and the problem source determined to be either production personnel did not follow the inspection instructions, or the instructions are not clear in the welder process.

• Brand Name: 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: 9584439
• Report Number: 3012307300-2020-00169
• Device Sequence Number: 534992
• Product Code: BTR
• UDI-Device Identifier: 15019315054082
• UDI-Public: 15019315054082
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 05/21/2020

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: Health Professional
• Device Model Number: 100/166/070
• Device Catalogue Number: 100/166/070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2019
• Supplement Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 05/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1