MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX SILICONISED PVC, ORAL/NASAL UNCUFFED TRACHEAL TUBE; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	100/111/035
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Occupation:matron for intensive care & high dependancy.Foreign: (b)(6).
Event or Problem Description
Information was received that the blue adaptor of a smiths medical portex siliconised pvc, oral/nasal uncuffed tracheal tube was difficult to remove.The adapter is noted to be removed in order to reduce the dead space in the tube post intubation.No adverse patient effects were reported.
Event or Problem Description
Additional information received stating infant required resusitation when blue end from additional tube was attached to the endotracheal tube.This event is now classified as a serious injury.
Additional Manufacturer Narrative
One endotracheostomy was returned for evaluation.Visual inspection of the device found it to have a damaged connector.Functional testing of the device included attempt at separating connector from tube with hands.The connectors were able to be separated from the tube.The reported customer complaint was not confirmed.The most probable cause of issue was determined that the product become damaged after it left the shm facilities.

• Brand Name: PORTEX SILICONISED PVC, ORAL/NASAL UNCUFFED TRACHEAL TUBE
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8282092
• Report Number: 3012307300-2019-00419
• Device Sequence Number: 13931088
• Product Code: BTR
• 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,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/02/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/27/2023
• Device Model Number: 100/111/035
• Device Catalogue Number: 100/111/035
• Device Lot Number: 3631841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2018
• Supplement Date Received by Manufacturer: 01/24/2019; 04/03/2019
• Initial Report FDA Received Date: 01/28/2019
• Supplement Report FDA Received Date: 02/22/2019; 05/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1