MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. RUSCH TRACHEAL TUBE, CUFFED, NASAL PREFORMED; TUBE, TRACHEAL (W/WO CONNECTOR)

Catalog Number	111782-000065
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported "prior to use & test, cuff line broken." there was no patient involvement or harm.
Event or Problem Description
It was reported "prior to use & test, cuff line broken." there was no patient involvement or harm.
Additional Manufacturer Narrative
(b)(4).The sample was returned and sent to the manufacturing site for evaluation.The manufacturing site reports "visual inspection was performed on the returned sample.It was observed that the side arm of the returned actual complaint sample is not attached to the main tube." it was also reported that there is 100% visual inspection on the side arm fitting and 100% leak test after assembling the inflation tube to the main tube, in addition to 100% visual inspection of the finished product inside packaging.A device history record review was performed and no relevant findings were identified.Based on the returned sample, the complaint was confirmed; however, a root cause for the issue could not be identified.The manufacturing site reports that 100% visual and functional testing is conducted at the manufacturing facility; therefore, a defect of this type would be detected prior to release.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: RUSCH TRACHEAL TUBE, CUFFED, NASAL PREFORMED
• 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: 19808823
• Report Number: 8040412-2024-00165
• Device Sequence Number: 18229805
• Product Code: BTR
• UDI-Device Identifier: 04026704325641
• UDI-Public: (01)04026704325641(11)231230(17)281130(10)40E23M5402(21)
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2024

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 Catalogue Number: 111782-000065
• Device Lot Number: 40E23M5402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2024
• Supplement Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/30/2023
• 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: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown