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

Model Number	IPN041502
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
It was reported that the balloon in the tube does not inflate properly, so it must be done manually every time, failure to inflate properly may cause the equipment to break out which may result in loss of air supply.No reported injury.
Event or Problem Description
It was reported that the balloon in the tube does not inflate properly, so it must be done manually every time, failure to inflate properly may cause the equipment to break out which may result in loss of air supply.No reported injury.
Additional Manufacturer Narrative
Qn#(b)(4).There was no sample returned for this complaint therefore actual defect reported could not be examined.Review on previous similar complaint for similar product catalogue was done as simulation purpose.One representative sample was investigated.Visual inspection was performed.There is not any obvious defect observed during the inspection.The cuff pressure was then inflated to 25mbar.The cuff pressure was observed to be maintained at 25 mbar.The sample was then immersed into the water and underwent the underwater leak test.No bubbles were observed flowing out from the sample during the underwater test.Color water test was then conducted by injecting color water into the cuff to further identify any point of leakage.There is no cuff leakage found.There was no sample returned for this complaint therefore actual defect reported could not be examined.Review on previous similar complaint for similar product catalogue was done and based on the investigation, no defect was found.The complaint on cuff could not be inflated could not be c onfirmed due to no sample returned.

• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 15912210
• Report Number: 8040412-2022-00337
• Device Sequence Number: 5486360
• Product Code: BTR
• UDI-Device Identifier: 44026704341427
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2022

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 Expiration Date: 05/28/2024
• Device Model Number: IPN041502
• Device Catalogue Number: 112082070
• Device Lot Number: 19FT29
• 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: 11/24/2022
• Supplement Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 12/03/2022
• Supplement Report FDA Received Date: 01/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown