MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. RUSCH SAFETY CLR MURPHY CUF ET; TUBE, TRACHEAL (W/WO CONNECTOR

Catalog Number	112082070
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "difficult laryngoscopy.Very easy bag mask ventilation (bmv).Narrow mouth and anterior larynx.2 x laryngoscopy and esophageal intubations were attempted.View without backward, upward, rightward pressure maneuver (burp).Easy bmv in between attempts.Sevo to maintain depth plus extra propofol boluses were given.Successful styletted, 7.0 rusch teleflex (high-volume, low-pressure cuff) ett placed.Oropharynx suctioned for small amount of blood.Noted prominent esophageal opening (likely from balloon inflation x 2) without bleeding or obvious tear.Due to fact that esophageal intubation x 2- thoracic surgery called to review with scope and rule out perforation/tear.No subcutaneous emphysema noted.The rusch endotracheal tubes are made of a material that is substantially less malleable than the regular preferred endotracheal tubes and as such are more likely to cause injury to the soft tissues of the pharynx during intubation.The patient was reported as fine post procedure.
Event or Problem Description
It was reported that: "difficult laryngoscopy.Very easy bag mask ventilation (bmv).Narrow mouth and anterior larynx.2 x laryngoscopy and esophageal intubations were attempted.View without backward, upward, rightward pressure maneuver(burp).Easy bmv in between attempts.Sevo to maintain depth plus extra propofol boluses were given.Successful styletted, 7.0 rusch teleflex (high-volume, low-pressure cuff) ett placed.Oropharynx suctioned for small amount of blood.Noted prominent esophageal opening (likely from balloon inflation x 2) without bleeding or obvious tear.Due to fact that esophageal intubation x 2- thoracic surgery called to review with scope and rule out perforation/tear.No subcutaneous emphysema noted.The rusch endotracheal tubes are made of a material that is substantially less malleable than the regular preferred endotracheal tubes and as such are more likely to cause injury to the soft tissues of the pharynx during intubation.The patient was reported as fine post procedure.
Additional Manufacturer Narrative
(b)(4) complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: RUSCH SAFETY CLR MURPHY CUF ET
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 22335458
• Report Number: 8040412-2025-00173
• Device Sequence Number: 8962882
• Product Code: BTR
• UDI-Device Identifier: 14026704341426
• UDI-Public: (01)14026704341426(11)240809(17)290731(10)40E24H1411(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K961837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2025

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 Catalogue Number: 112082070
• Device Lot Number: 40E24H1411
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2024
• 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: NOT REPORTED; NOT REPORTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown