MAUDE Adverse Event Report: ST PAUL PORTEX ENDOTRACHEAL TUBES SILICONIZED; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	100/166/065
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device serial number/lot number is unknown, no product information has been provided to date.A product sample was received and is awaiting evaluation and investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that when the customer was inserting the product in the patient, leakage of air from the cuff was observed.This event was seen in the two (2) products consecutively, and the third (3rd) product was intubated with no problem.No patient injury reported.
Additional Manufacturer Narrative
H10: no lot number was provided; therefore, device history record review could not be performed.Two product samples and five photos were received for evaluation.Visual and functional testing was performed.Visual inspection of the photos showed a rip on cuff.The returned samples were visually inspected at 12? to 16? and normal conditions of illumination to detect any condition that could cause a leak and a syringe was connected to pilot balloon to detect leaks.Rip was detected in cuff for two samples and a leakage was detected; complaint was confirmed.The root cause is the cuff was damaged during the use of the product since no leaks were reported in the pre-use check and according to the instructions for use the cuff could be damaged due to cuff nicks from teeth or instrumentation during intubation.No corrective action is required as there is no information if the product leaks in the pre-checked that suggest to the instruction for use.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX ENDOTRACHEAL TUBES SILICONIZED
• 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; 4-1-5, izumi-chuo, izumi-ku; minneapolis, MN 55442
• MDR Report Key: 16017324
• Report Number: 3012307300-2022-28010
• Device Sequence Number: 20517713
• Product Code: BTR
• UDI-Device Identifier: 15019315054075
• UDI-Public: 15019315054075
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K790312
• 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,Followup
• Report Date (Section B): 03/28/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 100/166/065
• Device Catalogue Number: 100/166/065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2022
• Supplement Date Received by Manufacturer: 01/26/2023
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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