MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. RUSCH FLEXI-SET CUFFED 8.0MM; TUBE, TRACHEAL (W/WO CONNECTOR

Model Number	IPN044687
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported: "hospital was using the endotracheal tube and said the cuff was not deflating when they were going to extract the ett.Additional information received: the pilot balloon was where the issue was.The connection point where the syringe and the pilot balloon meet specifically.No medical intervention was required".No patient injury or consequence reported.Patient condition reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the cuff and pilot balloon were deflated.No defects were observed.The cuff and pilot balloon were then inflated to 25mbar using a calibrated endotest and both were able to be inflated, and maintained pressure.No leakage was detected.The sample was then immersed in water and no bubbles were observed coming from the pilot balloon or cuff.Based on the investigation performed, the reported complaint could not be confirmed.Both cuff and pilot balloon were able to be inflated and deflated with no issues.
Event or Problem Description
It was reported: "hospital was using the endotracheal tube and said the cuff was not deflating when they were going to extract the ett.Additional information received: the pilot balloon was where the issue was.The connection point where the syringe and the pilot balloon meet specifically.No medical intervention was required".No patient injury or consequence reported.Patient condition reported as "fine".

• Brand Name: RUSCH FLEXI-SET CUFFED 8.0MM
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 12162995
• Report Number: 8040412-2021-00194
• Device Sequence Number: 19987480
• Product Code: BTR
• UDI-Device Identifier: 04026704547630
• UDI-Public: 04026704547630
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2021

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 Model Number: IPN044687
• Device Catalogue Number: 504580
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2021
• Initial Date Received by Manufacturer: 06/21/2021
• Supplement Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 08/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1