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

Model Number	IPN041502
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that while in use on a patient, the anesthesiologist sprayed the cannula with lidocaine as "common practice to relax the tissue and reduce inflammation" which caused the printed ink markings on the ett to come off.A 2nd cannula was used and sprayed with lidocaine which caused the same effect.At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.
Event or Problem Description
It was reported that while in use on a patient, the anesthesiologist sprayed the cannula with lidocaine as "common practice to relax the tissue and reduce inflammation" which caused the printed ink markings on the ett to come off.A 2nd cannula was used and sprayed with lidocaine which caused the same effect.
Additional Manufacturer Narrative
(b)(4).Additional information received on 31 may 2023 states that the issue was resolved as "another cannula of a different model was used".There was no patient harm or injury, the patient was discharged from the hospital.Complaint verification testing could not be performed as no sample was returned for analysis.Although the sample was not returned, the customer did provide a photo for evaluation.A visual exam was performed on the photo and it was observed that there was ink smeared on the inside of the packaging.The manufacturer reports "according to the complaint description, the user is using lidocaine on the tube.As per ifu there is a warning related to the use of lidocaine topical aerosols has been associated with the formation of pinholes in pvc cuffs.The use of a water soluble lubricant gel is recommended." a device history record review was performed and no relevant findings were identified.Based on the photo, the complaint was confirmed.The root cause is related to the use of lidocaine instead of a water soluble lubricant gel.

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17018885
• Report Number: 8040412-2023-00217
• Device Sequence Number: 17728099
• Product Code: BTR
• UDI-Device Identifier: 14026704341426
• UDI-Public: 14026704341426
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 05/04/2023

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: IPN041502
• Device Catalogue Number: 112082070
• Device Lot Number: KME22B2203
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2023
• Supplement Date Received by Manufacturer: 06/23/2023
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2022
• 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
• Patient Age: 34 YR
• Patient Sex: Female