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	02/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "torn product found while connecting breathing circuit to air way".No additional information provided at time of report.Patient condition unknown at time of report.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "torn product found while connecting breathing curcuit to air way".No additional information provided at time of report.Patient condition unknown at time of report.
Additional Manufacturer Narrative
(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the corrugated tubing was torn at the connector area.A device history record review was performed on a potential lot number reported by the customer (lot #kmh21j0110) and no relevant findings were identified.Based on the visual exam, the reported complaint was confirmed.The manufacturing site reports "the defect part was supplied by our supplier." a non-conformance was opened to address this issue.

• 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: 13667441
• Report Number: 8040412-2022-00044
• Device Sequence Number: 4659872
• Product Code: BZO
• UDI-Device Identifier: 04026704388769
• UDI-Public: 04026704388769
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 02/11/2022

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
• Device Model Number: IPN043837
• Device Catalogue Number: 20011
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2022
• Supplement Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 03/04/2022
• Supplement Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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