MAUDE Adverse Event Report: ST PAUL PORTEX TRACHEAL TUBE SILICONIZED PVC SOFT SEAL CUF; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	100/166/075
Medical Device Problem Code	Material Invagination (1336)
Health Effect - Clinical Code	Decreased Respiratory Rate (2485)
Date of Event	07/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.
Event or Problem Description
It was reported that after patient intubation a ventilation issue was observed.After examination via fibroscopy, visible folding of the intubation tube was found to be preventing ventilation.Tube was in place for fourteen days.Removal of the tube with guide and reintubation with a new tube resolved the issue.Additional information was received on (b)(6) 2022 stating no clinical consequence to the patient was observed.Premature tube change had to take place.Additional information received on (b)(6) 2022 stating the tube was bent around and between the base of the tongue and the pharynx about in the middle of the tubes.Incident occurred with three (3) patients after fourteen (14) days (patient 1), nine (9) days (patient 2) and one (1) day (patient 3).Intubation was not difficult for all three patients and under direct laryngoscopy.The patients were in intensive care unit.
Additional Manufacturer Narrative
H10: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample and four photos were received for evaluation.Visual inspection found the photos showed an inflation line occluded.No other analysis was performed.The root cause of the reported issue was found to be supplied component fault.Customer complaint notification was made to production personnel to explain the importance to adherence or following in the procedure by quality engineer on (b)(6)2022.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX TRACHEAL TUBE SILICONIZED PVC SOFT SEAL CUF
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15322268
• Report Number: 3012307300-2022-16822
• Device Sequence Number: 20305412
• Product Code: BTR
• UDI-Device Identifier: 15019315054099
• UDI-Public: 15019315054099
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K790312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2023

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: 07/20/2026
• Device Model Number: 100/166/075
• Device Catalogue Number: 100/166/075
• Device Lot Number: 4150640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2022
• Supplement Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown