MAUDE Adverse Event Report: ST PAUL PORTEX IVORY PVC, NORTH FACING, NASAL, PROFILE SOF; TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATIO

Model Number	100/133/075
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a pre-use check, the customer found a stain on the product.No patient injury reported.
Additional Manufacturer Narrative
Six photos were received for evaluation and found stained tube was observed; the complaint was confirmed.One (1) sample was returned for evaluation; the sample was received in unused conditions within its original package.The returned sample was visually inspected at 12 inches to 16 inches and normal conditions of illumination and revealed stained tube was found; the complaint was confirmed.No other analysis was performed.Based on the analysis conducted in the sample provided, contamination failure mode was confirmed.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX IVORY PVC, NORTH FACING, NASAL, PROFILE SOF
• Common Device Name: TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATIO
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; aichi pref.; minneapolis, MN 55442
• MDR Report Key: 15362694
• Report Number: 3012307300-2022-17955
• Device Sequence Number: 17509737
• Product Code: BTR
• UDI-Device Identifier: 15019315020360
• UDI-Public: 15019315020360
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K931735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/06/2022

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: Other
• Device Expiration Date: 03/11/2025
• Device Model Number: 100/133/075
• Device Catalogue Number: 100/133/075
• Device Lot Number: 3952561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 09/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown