MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ENDOTRACHEAL TUBE; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	100/189/080
Medical Device Problem Codes	Obstruction of Flow (2423); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Codes	Low Oxygen Saturation (2477); Decreased Respiratory Rate (2485)
Date of Event	02/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: month and year of event have been provided ,day is unknown.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 ett (endotracheal tube) tube was kinked and appeared to have weakness at approach 18cm/subglottic tubing.Unable to pass suction catheter, able to pass bronchoscopy with difficulty, unable to manually unkink.It was also reported that the patient required bronchoscopy, ett (endotracheal tub) change with sudation and subsequently de- recruited and required higher fi02 (fraction of inspired oxygen) overnight.Customer reported that they did not have the package for the faulty device.The lot number provided is from the item in the same stock location.Not the ideal one.
Additional Manufacturer Narrative
Other, other text: h6.Health impact and evaluation codes: updated.Eleven (11) photos were provided by the customer which were used to conduct the device analysis since the physical product was not returned for investigation.Photo one (1) shows a packaging label.Photos two and three show the front and back of a tracheal tube inside a biohazard bag; no dysfunctional conditions are observed.Photos four and five show the whole device?s front and back of the tracheal tube where the suction line is observed to be filled with fluid; no kink or other dysfunctional conditions are observed in any of the tubes.Photos six and seven show a close-up of the distal end of the unit where the cuff is observed to be deflated and covered in fluid.Photos eight and nine show a close-up of the connection between the tracheal tube, inflation line, and suction line; no kink or other dysfunctional conditions are observed.Photos ten and eleven show the inflation line balloon; no damage or dysfunctional conditions are observed.The reported failure mode, kinked tube, is not confirmed.No product has been received to conduct a functional test.A device history record (dhr) reviewed showed no reported nonconformance?s during the manufacturing of the reported lot number.No corrective actions are taken as the complaint cannot be confirmed.If the device is returned the manufacturer will re-open the investigation for further device analysis.

• Brand Name: PORTEX ENDOTRACHEAL 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; stott lane; minneapolis, MN 55442
• MDR Report Key: 16439820
• Report Number: 3012307300-2023-01667
• Device Sequence Number: 3135669
• Product Code: BTR
• UDI-Device Identifier: 15019315059544
• UDI-Public: 15019315059544
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K081086
• 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): 05/31/2023

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 Model Number: 100/189/080
• Device Catalogue Number: 100/189/080
• Device Lot Number: 4264598
• 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: 02/06/2023
• Supplement Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 02/24/2023
• Supplement Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2022
• 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 Sex: Unknown