MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. TRACH-VENT+STERILE; CONDENSER, HEAT AND MOISTURE

Catalog Number 41311U

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 07/28/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "the nurse found connector broken when using on patient".At the time of this report the customer has not returned our requests for additional information.If additional information is received, the complaint file will be updated.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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.

Event Description

It was reported that "the nurse found connector broken when using on patient".At the time of this report the customer has not returned our requests for additional information.If additional information is received, the complaint file will be updated.

• Brand Name: TRACH-VENT+STERILE
• Type of Device: CONDENSER, HEAT AND MOISTURE
• 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: 17899631
• MDR Text Key: 326248851
• Report Number: 8040412-2023-00362
• Device Sequence Number: 1
• Product Code: BYD
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/20/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 41311U
• Device Lot Number: KMH21B0065
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/20/2023
• Initial Date FDA Received: 10/09/2023
• Supplement Dates Manufacturer Received: 11/09/2023
• Supplement Dates FDA Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1