MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX SILICONISED PVC, ORAL/NASAL MURPHY EYE UNCU; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	100/141/025
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the tube released the blue fitting piece from the rest of the tube.No additional information.
Additional Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No problems or issues were identified during this device history record review.A product sample was received for evaluation.Visual and functional testing were performed.One (1)sample was returned; sample was returned in unused conditions within original package.Per visual inspection, connector detached from tube was received however, its not possible to confirm the reported failure mode since was not confirmed connector not enough assembled inside the tube before the use that could cause a detachment.The root cause of the reported issue could not be confirmed as the reported issue could not be replicated at the time of the device evaluation.No action taken was performed since the complaint was not confirmed.

• Brand Name: PORTEX SILICONISED PVC, ORAL/NASAL MURPHY EYE UNCU
• 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): NULL; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; centro empresarial tambore; minneapolis, MN 55442
• MDR Report Key: 13888863
• Report Number: 3012307300-2022-05229
• Device Sequence Number: 990509
• Product Code: BTR
• UDI-Device Identifier: 15019315019029
• UDI-Public: 15019315019029
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2023

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: 10/02/2024
• Device Model Number: 100/141/025
• Device Catalogue Number: 100/141/025
• Device Lot Number: 3877721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2022
• Supplement Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2019
• 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