MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. RUSCH CRVD REINF CUFF ET 7.0MM; TUBE, TRACHEAL (W/WO CONNECTOR

Model Number	IPN040969
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported on (b)(6) 2022 that the doctor found the cuff to be leaking before use on a patient.A new device was changed.There was no impact on the patient.The device was not used on the patient.
Additional Manufacturer Narrative
(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that there was tape on the tube and stain marks on the cuff indicating the tube has been used by the customer.Functional testing was then performed and the cuff was inflated between 20-30 mbar.The cuff could not stay inflated.The sample was then immersed in water for leak testing.Air bubbles were observed coming from the cuff sleeve.The area was observed under magnification and it was observed that there was poor welding on the cuff sleeve.A device history record review was performed and no relevant findings were identified.The complaint has been confirmed.A non-conformance was opened to address this issue.
Event or Problem Description
It was reported on (b)(6) 2022, that the doctor found the cuff to be leaking before use on a patient.A new device was changed.There was no impact on the patient.The device was not used on the patient.

• Brand Name: RUSCH CRVD REINF CUFF ET 7.0MM
• Common Device Name: 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 15744814
• Report Number: 8040412-2022-00317
• Device Sequence Number: 5355083
• Product Code: BTR
• UDI-Device Identifier: 14026704340962
• UDI-Public: 14026704340962
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2022

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
• Device Model Number: IPN040969
• Device Catalogue Number: 103902-000070
• Device Lot Number: KME21J0617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2022
• Supplement Date Received by Manufacturer: 11/25/2022
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown