MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. RUSCH FLEXI-SET CUFFED 7.0MM; TUBE, TRACHEAL (W/WO CONNECTOR

Model Number	IPN044685
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Airway Obstruction (1699)
Date of Event	04/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "[on] (b)(6) 2021 5:19pm pt intubated in the or with 7.0 teleflex ett.In icu - (b)(6) am pt had peak ventilator pressures of 10 - 11 cm h20 then they began reading 34-38 cm h2o, patient was agitated and had difficulty passing a suction catheter.(b)(6) 12:29pm removed the ett and reintubated, ventilator peak pressures returned to baseline of 10-11 cm h20".Patient condition reported as "fine".
Additional Manufacturer Narrative
(b)(4).The actual device sample was not returned for evaluation; therefore, one sample was retrieved from a production lot at the manufacturing facility.A visual inspection was conducted on the production sample and no defects were observed.Functional testing was also performed and the cuff was inflated to 25mbar using calibrated endotest.The cuff was able to maintain pressure.The sample was then immersed in water and no air bubbles were observed flowing out from the cuff indicating no leaks.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed.From the customer description it seems that there's a possibility that the tube was leaking during use or there was a kink that was blocking the air to the patient; however, without the actual sample the real root cause could not be determined.
Event or Problem Description
It was reported "[on] 4/15/21 5:19pm pt intubated in the or with 7.0 teleflex ett.In icu - april 16 am pt had peak ventilator pressures of 10 - 11 cm h20 then they began reading 34-38 cm h2o, patient was agitated and had difficulty passing a suction catheter.April 16 - 12:29pm removed the ett and reintubated, ventilator peak pressures returned to baseline of 10-11 cm h20".Patient condition reported as "fine".

• Brand Name: RUSCH FLEXI-SET CUFFED 7.0MM
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 11843248
• Report Number: 8040412-2021-00135
• Device Sequence Number: 11490751
• Product Code: BTR
• UDI-Device Identifier: 04026704547616
• UDI-Public: 04026704547616
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K961837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2021

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: No Information
• Device Expiration Date: 09/28/2025
• Device Model Number: IPN044685
• Device Catalogue Number: 504570
• Device Lot Number: KME20K2057
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 06/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VENTILATOR; VENTILATOR