MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. RUSCH CRVD REINF CUFF ET 7.0MM

Model Number	IPN040969
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that "before use to patient rusch ett no 7, doctor testing first by inflate the balloon 7cc, but the balloon ett deflated by self, so the ett was change with the new ett".No patient involvement reported.
Event or Problem Description
It was reported that "before use to patient rusch ett no 7, doctor testing first by inflate the balloon 7cc, but the balloon ett deflated by self, so the ett was change with the new ett".No patient involvement reported.
Additional Manufacturer Narrative
(b)(4).It was reported that the sample is not available for return; therefore, ten samples were selected from current production at the manufacturing facility for evaluation.A visual exam was conducted and no defects were observed.Cuff pressure was tested on the samples and the cuffs on all ten samples could be inflated without any issues and they maintained pressure at 25mbar with no abnormalities.The production samples were then immersed in water for leak testing.No bubbles were observed flowing out from the samples during the underwater test indicating there were no leaks.There is 100% leak test performed in manufacturing in which any leakage would be identified prior to release from the manufacturing facility.Simulation using production representative sample shows no decreased in cuff pressure and no leakage at side arm joint was observed.Without the actual device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the a vailable information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: RUSCH CRVD REINF CUFF ET 7.0MM
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 11619728
• Report Number: 8040412-2021-00102
• Device Sequence Number: 16893762
• Product Code: BTR
• UDI-Device Identifier: 14026704340962
• UDI-Public: 14026704340962
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• 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): 03/22/2021

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 Model Number: IPN040969
• Device Catalogue Number: 103902-000070
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1