MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRA; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	100/189/070
Medical Device Problem Codes	Partial Blockage (1065); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: 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 upon testing cuff prior to intubation, there were tiny bubbles within soft-seal cuff.No patient involvement.
Additional Manufacturer Narrative
Email is: regulatory.Responses@icumed.Com.Eleven (11) device samples were received, three (3) in used condition without the original packaging and eight (8) unused with the original pouch closed.During the visual inspection, contamination was found to be present in each of the returned samples.The complaint was confirmed due to the presence of contamination or foreign material in all samples.The investigation determined that the root cause was from the raw material from the supplier.The supplier found that a certain component of the plasticizer had increased to a level that made it less compatible with pvc and therefore could migrate to the surface as a powder or residue.While the component level was within supplier's specification of plasticizer, the supplier agreed that the level was higher than in past years.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.A significantly tighter raw material specification was implemented for the component(s) of the terminator acid blend that migrated to the surface.This tighter specification will prevent this migration and return this plasticizer to its original state.

• Brand Name: PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRA
• 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 17313451
• Report Number: 3012307300-2023-07164
• Device Sequence Number: 4058124
• Product Code: BTR
• UDI-Device Identifier: 15019315059520
• UDI-Public: 15019315059520
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K081086
• 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): 02/22/2024

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: 11/01/2025
• Device Model Number: 100/189/070
• Device Catalogue Number: 100/189/070
• Device Lot Number: 4044243
• 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: 06/27/2023
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2020
• 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