MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. CRVD REINF CUFF ET 7.0MM; TUBE, TRACHEAL (W/WO CONNECTOR)

Catalog Number 103902-000070

Device Problem Inflation Problem (1310)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/22/2023

Event Type  malfunction  

Event Description

It was reported that "hcp tested product and found failed to inflate pilot balloon (leakage on balloon)".It was occurred prior to use on patient".No patient involvement.

Manufacturer Narrative

Qn# (b)(4).Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that "hcp tested product and found failed to inflate pilot balloon (leakage on balloon)".It was occurred prior to use on patient".No patient involvement.

Manufacturer Narrative

Qn#(b)(4).The sample was returned and sent to the manufacturing site for investigation.The manufacturing site reports the cuff was unable to be inflated at all.Blue dye was used to check for leakage or blockage at the cuff, side arm, or tube and it was found there was a blockage at the side arm of the tube.The complaint has been confirmed.A non-conformance was opened to address this issue.

• Brand Name: CRVD REINF CUFF ET 7.0MM
• Type of Device: 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: 17336856
• MDR Text Key: 319498813
• Report Number: 8040412-2023-00282
• Device Sequence Number: 1
• Product Code: CBI
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 103902-000070
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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