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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that "the material of several devices of this lot is breaking.Defect was noted prior to use".No patient involvement reported.
Additional Manufacturer Narrative
Qn#(b)(4).Twenty representative samples were returned by the customer for investigation.A visual exam was performed and no defects were observed.The manufacturing site reports that in the current manufacturing procedure 100% leak testing is conducted during the assembly process and a 100% visual inspection is also conducted at the packing area; thus any defective product will be detected prior to release.The manufacturing site also reports that ten pieces of this product code were taken from current production at the manufacturing facility.A visual exam was conducted along with leak testing.No issues were detected.All ten samples passed the leak test.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 or Problem Description
It was reported that "the material of several devices of this lot is breaking.Defect was noted prior to use".No patient involvement reported.

• 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: 13446668
• Report Number: 8040412-2022-00023
• Device Sequence Number: 4321724
• 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): 01/13/2022

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
• Device Expiration Date: 04/30/2026
• Device Model Number: IPN043837
• Device Catalogue Number: 20011
• Device Lot Number: KMH21F0394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2022
• Supplement Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 03/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2021
• 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