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

Model Number	100/111/025
Medical Device Problem Codes	Material Fragmentation (1261); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2022
Type of Reportable Event	Serious Injury
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 during reintubation, customer was unable to pass suction catheter down the trach tube.The blue connector seemed to be at an odd angle as it was inserted into the tube itself.Assessment noted the blue [connector] of trach tube (the part that fits into the tube) was chipped and a small segment had broken off.Unsure if broken prior to use or whilst in-situ as it was a difficult and timely intubation.Medics were informed and baby was assessed.The trach tube was removed from use and replaced.An x-ray of the chest was performed to rule out a foreign object in lung field.No evidence of blockage found so it was decided to continued with current plan of care.No interference with ventilation noted.No injury.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product sample nor photos were received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: SILICONISED PVC, ORAL/NASAL UNCUFFED TRACHEAL TUBE
• 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; birmingham heartlands hospital; minneapolis, MN 55442
• MDR Report Key: 15294737
• Report Number: 3012307300-2022-16224
• Device Sequence Number: 2658258
• Product Code: BTR
• UDI-Device Identifier: 15019315018848
• UDI-Public: 15019315018848
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K790312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/20/2026
• Device Model Number: 100/111/025
• Device Catalogue Number: 100/111/025
• Device Lot Number: 4141293
• Was Device Available for Evaluation?: No
• 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: 07/27/2022
• Supplement Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2021
• 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 Age: 1 DA
• Patient Sex: Female
• Patient Weight: 625 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American