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

Model Number	100/166/070
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2022
Type of Reportable Event	Malfunction
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 additional reportable information becomes available.
Event or Problem Description
It was reported that the nurse found the cuff leaking while testing before use.No injury reported.
Additional Manufacturer Narrative
Device evaluation: one sample was returned for investigation.The returned sample was received in used condition without original packaging.The sample was visually inspected under normal conditions of illumination to detect any condition that could cause the failure mode reported.No defects were detected.Sample received was submerged under water to detect leaks.A leakage was detected at the joint between the tube and cuff; the complaint was confirmed.The sample returned was connected to leak tester machine to identify a leak.Leakage was detected.Based on the analysis conducted in the sample provided, a leaking failure mode was confirmed.The failure condition was possibly due to the assembly process not being followed correctly (assembly error).The problem source was traced to manufacturing.For corrective action a customer complaint notification was sent to production personnel to explain the importance of adherence to the manufacturing procedure.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 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; bangna-trad road, bangna nuea; minneapolis, MN 55442
• MDR Report Key: 15799221
• Report Number: 3012307300-2022-27173
• Device Sequence Number: 4674835
• Product Code: BTR
• UDI-Device Identifier: 15019315054082
• UDI-Public: 15019315054082
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K790312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2023

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: Health Professional
• Device Expiration Date: 07/27/2023
• Device Model Number: 100/166/070
• Device Catalogue Number: 100/166/070
• Device Lot Number: 3682405
• 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: 11/08/2022
• Supplement Date Received by Manufacturer: 02/13/2023
• Initial Report FDA Received Date: 11/15/2022
• Supplement Report FDA Received Date: 06/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2018
• 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
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian