MAUDE Adverse Event Report: RUSCH CURVED REINFORCD CUFF ET; TUBE, TRACHEAL (W/WO CONNECTOR

Model Number	IPN040971
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the doctor found ballon leaking and pilot ballon didn t inflate".No patient harm or injury reported.Patient condition reported as "fine".
Additional Manufacturer Narrative
(b)(4).The sample was returned for evaluation.A visual exam was performed and no defects were observed.Functional testing was then performed and the cuff and pilot balloon were inflated to 25mbar using a calibrated endotest meter.The cuff could not stay inflated.The sample was then immersed in water for leak testing.Air bubbles were observed coming from the pilot balloon indicating there was a leak.The area of leakage was observed under magnification and a tear mark was found.A device history record review was performed and no relevant findings were identified.The complaint of leakage was confirmed; however, a root cause for the issue could not be determined.There is a 100% leak test conducted at the manufacturing facility whereby any leakage would be detected prior to release.
Event or Problem Description
It was reported that "the doctor found ballon leaking and pilot ballon didn t inflate".No patient harm or injury reported.Patient condition reported as "fine".

• Brand Name: RUSCH CURVED REINFORCD CUFF ET
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR
• MDR Report Key: 12518574
• Report Number: 8040412-2021-00226
• Device Sequence Number: 17141366
• Product Code: BTR
• UDI-Device Identifier: 14026704340986
• UDI-Public: 14026704340986
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2021

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: Health Professional
• Device Expiration Date: 06/28/2025
• Device Model Number: IPN040971
• Device Catalogue Number: 103902-000080
• Device Lot Number: 20GG40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• Initial Date Received by Manufacturer: 09/01/2021
• Supplement Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 09/23/2021
• Supplement Report FDA Received Date: 11/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1