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

Catalog Number	198-32L
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/07/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received indicating that the fore end of a smiths medical portex endobronchial double lumen tube was bent.There was no reported injury to the patient.
Additional Manufacturer Narrative
Additional information received: updated adverse event or product problem,outcomes attributed to adverse event, and type of reportable event.It was also reported on (b)(6)2019 that a tube change out was required.Device evaluation: one portex sample was returned for evaluation.The sample was received in used conditions without its original packaging.Upon immediate visual inspection, it was determined the tube was kinked and the stylet was removed from the device.Operator training records were reviewed to ensure operators are trained.No discrepancies were found.Production was also audited during thirty two (32) units finding no discrepancies.A review of the manufacturing process was conducted and was considered adequate and correct.Based on the evidence and investigation, the complaint was confirmed.The problem source was stated to be unknown.However, it was noted the most probable sources of the reported event were either of the following: the product become damaged after it left the facilities (since it is 100% inspected) or a possible lack of detection by production personnel.

• Brand Name: PORTEX ENDOBRONCHIAL TUBES
• 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: 8488659
• Report Number: 3012307300-2019-01833
• Device Sequence Number: 19300542
• Product Code: CBI
• UDI-Device Identifier: 15019315058608
• UDI-Public: 15019315058608
• Combination Product (Y/N): N
• PMA/510(K) Number: K953483
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2019

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: 10/09/2023
• Device Catalogue Number: 198-32L
• Device Lot Number: 3715074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2019
• Supplement Date Received by Manufacturer: 04/26/2019
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 08/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention