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

Model Number	100/189/085
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation in progress.
Event or Problem Description
It was reported that no anomaly was observed in the product at a pre-use check.However, 10 days after the start of use, the suction line got torn off at a point approximately 2 cm away from the tubing connection part.There were no adverse patient effects.
Event or Problem Description
Investigation completed on a smiths medical intubation|portex endotracheal tube.Summary in h 10.
Additional Manufacturer Narrative
Investigation completed on a smiths medical intubation|portex endotracheal tubes sacett.Device arrived in original package with p/n100/189/085.Visually inspected from 12"-24" and this revealed suction line detached with picture provided.Review with quality engineer on 17/mar/2020 p/n 100/189/080 l/n 3952513.P/n 100/189/085 and p/n 100/189/080 belongs to the same product family and follows the same procedure.The device passed 100% review.The most probable root cause is that the product become damaged after it left the shm facilities due to the product is 100% visual inspected by damage and 100% flow tested.No fault can be found with device.As device is manipulated with human contact with pressure against objects sharp or bent may cause event.Updated b 1, b 3, b 4, b 5, g 7, h 1, h 2, h 3, h 6 , h 10.

• Brand Name: PORTEX ENDOTRACHEAL TUBES SACETT
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis, mn
• MDR Report Key: 9753503
• Report Number: 3012307300-2020-01548
• Device Sequence Number: 14279832
• Product Code: BTR
• UDI-Device Identifier: 15019315059551
• UDI-Public: 15019315059551
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K081086
• 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): 05/29/2020

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 Model Number: 100/189/085
• Device Catalogue Number: 100/189/085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2020
• Supplement Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 05/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1