MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX BLU SELECT SUCTIONAID CUFFED TRACHEOSTOMY; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number 101/860/080

Device Problem Obstruction of Flow (2423)

Patient Problems Hypoventilation (1916); Low Oxygen Saturation (2477); Respiratory Insufficiency (4462)

Event Date 09/13/2023

Event Type  Injury  

Manufacturer Narrative

Other, other text: d4: lot number, expiration date, and h4: manufacture date are unknown, no information has been provided to date.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 Description

It was reported that there was deterioration of the patient's respiratory condition.The patient's respiratory condition worsened while using the product.Event details: at 9:00 on september 13th, the tracheostomy tube was replaced.After that, a hypoventilation alarm occurred, spo2 decreased, ventilation was continued with hand mask ventilation.Then suctioning of secretion improved the ventilation temporarily.The hypoventilation alarm of the ventilator repeatedly sounded.Suctioning was administered, but the patient breathing condition worsened when changing patient position.At 22:15, spo2 dropped to the 70% range during patient position change, and the tracheal cannula was replaced with another tracheostomy tube.After that, the patient's respiratory condition stabilized.

Manufacturer Narrative

Email is: regulatory.Responses@icumed.Com.Evaluation codes: updated device evaluation: one decontaminated sample was received for investigation.Under visual inspection the sample appeared to be in good condition, no signs of damage.Inflation testing was repeated on the received sample.It was confirmed that after 12 hours the cuff was still fully inflated.Based on results of visual inspection and functional testing there was not found any failure of device.Complaint was not confirmed.No device history report (dhr) review was performed because no lot number provided and there was no lot number printed on product flange.No trend of similar customer complaints was identified.No actions taken.

• Brand Name: PORTEX BLU SELECT SUCTIONAID CUFFED TRACHEOSTOMY
• Type of Device: TUBE, TRACHEOSTOMY (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: 18057044
• MDR Text Key: 327185450
• Report Number: 3012307300-2023-10176
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019517076158
• UDI-Public: 15019517076158
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K173384
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 101/860/080
• Device Catalogue Number: 101/860/080CZ
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/17/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention