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

Model Number	IPN041504
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Reported event: pharmacy personnel reports that an oral/nasal endotracheal tube is returned because when it was opened from the primary packaging the anesthesiologist observes that the balloon is perforated, so a new cuff was requested to continue with the procedure, the product was discarded.
Event or Problem Description
Reported event: pharmacy personnel reports that an oral/nasal endotracheal tube is returned because when it was opened from the primary packaging the anesthesiologist observes that the balloon is perforated, so a new cuff was requested to continue with the procedure, the product was discarded.
Additional Manufacturer Narrative
(b)(4).Complaint reported that "pharmacy personnel reports that an oral/nasal endotracheal tube is returned because when it was opened from the primary packaging the anesthesiologist observes that the balloon is perforated, so a new cuff is requested to continue with the procedure, the product is discarded.Prior to use on a patient during inspection/functional testing.There was no sample received for verification, or no photo therefore, this complaint description could not be confirmed as reported.As simulation test, one piece of actual sample from previous similar complaint defect.Visual inspection conducted on the sample found no abnormality observed.The cuff able to maintain its pressure at 25mbar and the water leak test was then performed on the sample to observe if there are any bubbles flowing out from the cuff.There are no bubbles flowing out from the cuff.Based on the investigation conducted, defect mode of cuff leakage cannot be confirmed as there is no sample received or photograph for verification.

• Brand Name: 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16221770
• Report Number: 8040412-2023-00019
• Device Sequence Number: 7492664
• Product Code: BTR
• UDI-Device Identifier: 14026704341440
• UDI-Public: 14026704341440
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K961837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 12/27/2022

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
• Operator of Device: Health Professional
• Device Model Number: IPN041504
• Device Catalogue Number: 112082080
• Device Lot Number: KME22A2966
• 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: 12/27/2022
• Supplement Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 01/22/2023
• Supplement Report FDA Received Date: 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2022
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Age: 36 YR
• Patient Sex: Female