MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. TRACHEAL TUBE, CUFFED; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number IPN041491

Device Problem Disconnection (1171)

Patient Problem Low Oxygen Saturation (2477)

Event Date 09/26/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "the cob connector disconnected from the tube.Patient desaturated several times.Patient was a covid patient and had other medical background.Patient was coughing a lot and disconnections occurred when he was coughing, he was also moving.The patient death is not linked to the incident with the issue of the connector.There was no oily substance on the connector.The cob connector was properly inserted.Consequence was that patient was re-intubated.The disconnection was observed several days after intubation".Further information received states that the cause of death is "acute respiratory failure on covid".

Manufacturer Narrative

(b)(4).The reported complaint on 15 mm connector on ett had disconnected from tube could not be confirmed based upon the investigation of the returned sample.The customer returned a representative sample in an unopened pouch and no connector damage was observed upon visual inspection.The tube has an insertion mark, indicating that the connector was previously inserted at the tube.As per product drawing, the et connector should be inserted halfway in and as per measurement from the representative sample received, the insertion depth of connector to tube is meeting the spec >8mm which is 8.72mm.As per the ifu, the connector assembly features of et tube were designed in such a way that the connector can be removed and connected back to the tube when the tube required to be cut to length.There is precaution stated in the ifu that the 15mm connector should be firmly seated in the tracheal tube to prevent disconnected during use.A device history record review was performed, and no relevant findings were identified.The product requirement was meeting specification and no oily surface found on tube or connector.Teleflex will continue to monitor and trend on complaints of this nature.Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that "the cob connector disconnected from the tube.Patient desaturated several times.Patient was a covid patient and had other medical background.Patient was coughing a lot and disconnections occurred when he was coughing, he was also moving.The patient death is not linked to the incident with the issue of the connector.There was no oily substance on the connector.The cob connector was properly inserted.Consequence was that patient was re-intubated.The disconnection was observed several days after intubation".Further information received states that the cause of death is "acute respiratory failure on covid".

• Brand Name: TRACHEAL TUBE, CUFFED
• Type of Device: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• Manufacturer (Section G): TELEFLEX MEDICAL SDN. BHD.; lot no : pt2577 jalen perusahaan; 4 kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17969784
• MDR Text Key: 326125834
• Report Number: 8040412-2023-00359
• Device Sequence Number: 1
• Product Code: BTR
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN041491
• Device Catalogue Number: 112082-000070
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1