MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX CLEAR PVC, ORAL, SOFT SEAL CUFF NORTH POLA; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	100/136/065
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.Three (3) photos were received for evaluation and no defects were found regarding leak.One (1) sample was returned for evaluation.The sample was received in used conditions within its original packaging.The returned sample was visually inspected at a distance of 12 inches to 16 inches and normal conditions of illumination.No defects were found.Functional testing revealed the returned sample was inflated using a syringe with no difficulties to cuff inflating was detected.No other analysis was performed.The root cause for the reported issue cannot be determined since no defects were found in the sample received for evaluation.No corrective action is required since the complaint was not confirmed.Operator of device is patient/consumer.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported that during a pre-use check, the customer found difficulty in inflating the cuff.No patient injury was reported.

• Brand Name: PORTEX CLEAR PVC, ORAL, SOFT SEAL CUFF NORTH POLA
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 7-15-26 fukushima,; minneapolis, MN 55442
• MDR Report Key: 15362507
• Report Number: 3012307300-2022-17936
• Device Sequence Number: 12068999
• Product Code: BTR
• UDI-Device Identifier: 15019315021305
• UDI-Public: 15019315021305
• 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: Lay User/Patient
• Device Expiration Date: 03/01/2025
• Device Model Number: 100/136/065
• Device Catalogue Number: 100/136/065
• Device Lot Number: 3936670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• 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: 03/26/2020
• 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