MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. HUDSON HUMID-VENT FLEX TUBE; SET, TUBING AND SUPPORT, VENTI

Model Number	IPN043837
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the material of the devices is tearing open.Multiple attempts for additional information was requested to the customer has been unsuccessful.Patient condition unknown at time of report.
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that "the material of the devices is tearing open".Multiple attempts for additional information was requested to the customer has been unsuccessful.Patient condition unknown at time of report.
Additional Manufacturer Narrative
Qn#(b)(4).Complaint verification testing could not be performed as the customer has reported that the sample is not available for investigation; however, the customer did provide a photo.The photo was reviewed and it was confirmed that the tubing was torn.The manufacturing site reports: based on the observation, this complaint is confirmed.The defect part was supplied by our supplier.In manufacturing, a non-conformance (nc) has been raised to address this issue and root causes with corrective actions will be implemented through this nc process.

• Brand Name: HUDSON HUMID-VENT FLEX TUBE
• Common Device Name: SET, TUBING AND SUPPORT, VENTI
• 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: 14317865
• Report Number: 8040412-2022-00109
• Device Sequence Number: 5270742
• Product Code: BZO
• UDI-Device Identifier: 04026704388769
• UDI-Public: 04026704388769
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2022

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: IPN043837
• Device Catalogue Number: 20011
• Device Lot Number: UNKNOWN
• 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: 04/11/2022
• Supplement Date Received by Manufacturer: 05/27/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 06/08/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown