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

Model Number	100/166/075
Medical Device Problem Codes	Material Integrity Problem (2978); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/16/2019
Type of Reportable Event	Malfunction
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 torn.The product was removed and returned for analysis.There were no reported adverse effects.
Additional Manufacturer Narrative
Device evaluation: one (1) sample was returned for evaluation from p/n 100/166/070 with lot number reported as unknown; the sample was received in used condition without its original packaging.During visual inspection it was observed the inflation line cut.In order to reproduce the failure mode, the following scenarios were performed: 1.A line of inflation was cut with a single side razor blade.Result: the cut marks are different that the ones in the sample returned by the customer.2.Inflation line cut by stretching the sample with hands.Result: it was observed that the cut is not straight; samples could have been stretched in both instances since it can been seen that they have similar marks on the detach inflation line.Conclusion: based in the evidence collected with the recreation of the failure mode, it can be concluded that the inflation line was stretch until it broke, since 100% leak test is performed, there is no possibility sample can be tested if the line is cut or detached.The most probable root cause is that the product become damaged after it left the shm facilities since product is 100% leak tested, there is no possibility to test the material if line is cut or detached.No corrective actions are required since there is no information to suggest that the product was damaged during manufacture.

• 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: 9584435
• Report Number: 3012307300-2020-00170
• Device Sequence Number: 535132
• Product Code: BTR
• UDI-Device Identifier: 15019315054099
• UDI-Public: 15019315054099
• 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): 03/19/2020

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: 100/166/075
• Device Catalogue Number: 100/166/075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2019
• Supplement Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1