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

Catalog Number	100/111/035
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/04/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that a smiths medical endotracheal tube was found to be stuk and could not be removed.The cuff had to be cut from the et tube in order to fix the inline suction and ventilate this way.
Additional Manufacturer Narrative
Device evaluation: five portex endotracheal devices were returned for evaluation.Three of the samples were new and two were used.The returned devices were visually inspected.This inspection showed that one of the blue endotracheal tube connectors was damaged.The blue endotracheal tube connector is likely the component the reporter was referring to as the "blue cuff" that became "stuck".The remaining returned samples were given functional testing.The investigator attempted to separate the tube connector from the tube using hand force only.The tube connectors could be separated by hand force for all remaining samples.No sticking was observed.In addition, the device history record was reviewed for the reported lot number.The review showed no related observations identified to suggest the reported issue was observed during production.The manufacturing facility also performed a review of the manufacturing process.The review showed that assembly process was being performed as per procedures.The manufacturing facility also performed an in-process visual inspection of 32 products that were in the assembly area: this inspection showed no issues with the products being assembled.In effort to induce the condition seen on the used device that was returned, the investigator took a sample blue tube connector and pressed the connector against a sharp surface.The damage that occurred was physically similar to the damage seen on the returned sample.Following review of manufacturing procedures and investigation of the returned samples, the complaint allegation was confirmed.However, the investigation could not determine when the damage to the tube connector occurred.Two possible problem sources were noted as either of the following: the product become damaged after it left the facilities or a possible lack of detection by production personnel.

• Brand Name: PORTEX® ENDOTRACHEAL TUBE
• Common Device Name: TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8219773
• Report Number: 3012307300-2019-00078
• Device Sequence Number: 13502070
• Product Code: CBI
• UDI-Device Identifier: 15019315018862
• UDI-Public: 15019315018862
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2019

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 Catalogue Number: 100/111/035
• Device Lot Number: 3631841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2018
• Supplement Date Received by Manufacturer: 06/02/2019
• Initial Report FDA Received Date: 01/04/2019
• Supplement Report FDA Received Date: 07/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1