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

Model Number 198-35L

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Information was received indicating that during intubation of a patient with a smiths medical portex® endobracheal tube, difficulty was met.It was reported that the degree of curve to the tube's tip was noted to be varied.There were no reported adverse effects.

Manufacturer Narrative

Investigation completed on a smiths medical intubation|portex endobronchial tubes .3) products from p/n 198-37l l/n 3666522; the returned samples were received in new conditions with their original closed packaging.No discrepancies were revealed in the tip of the tube upon visual inspection 12"-16" with no discrepancies observed with the tip of tube.Pictures were sent to confirm this issue on (b)(6) 2020 p/n 198-35l l/n 3977828 an audit was done with quality engineer and device passed 100%.The root cause is hypothesized as lack of detection with personal in production and damage to product after leaving shm facilities, since product is 100% inspected with the fixture eng-0292-t008.Action was taken to train the production personnel in the procedure pict 0068 rev.107 stylet bender and assembly (ebt area) by quality engineer on (b)(6) 2020.

Event Description

Investigation completed on a smiths medical intubation|portex endobronchial tubes.Summary in h 10.

• Brand Name: PORTEX ENDOBRACHEAL TUBE
• Type of Device: TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, mn
• MDR Report Key: 10029174
• MDR Text Key: 190022271
• Report Number: 3012307300-2020-03786
• Device Sequence Number: 1
• Product Code: CBI
• UDI-Device Identifier: 15019315058615
• UDI-Public: 15019315058615
• Combination Product (y/n): N
• PMA/PMN Number: K953483
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/19/2022
• Device Model Number: 198-35L
• Device Catalogue Number: 198-35L
• Device Lot Number: 3808872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2020
• Date Manufacturer Received: 04/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1