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	Fracture (1260)
Health Effect - Clinical Code	Decreased Respiratory Rate (2485)
Date of Event	11/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "there was an anesthesia stat in the or this week related to decreased etco2/circuit leak that occurred in the middle of a case that was ultimately traced to a small defect/crack in the corrugated extension tubing".Specific patient information unknown at time of reporting.
Additional Manufacturer Narrative
Qn#(b)(4).The actual sample was not returned; however; the customer provided a photo for evaluation.The manufacturing site reviewed the photo and reported the following: "based on the photo provided as above, the tube was torn.The torn happened may due to mishandling during use.The reported defect was detected during use on patient.This defect happened due to extra force applied during twisting the tube.Further investigation could not be conducted to identify the defect on the complaint sample since there is no returned sample.In manufacturing site, 100% visual inspection and leak testing was conducted to this product.The leak tester will reject the device if there is any leak caused from the torn tube.There is very unlikely for the torn products will be released for shipment.In ifu mention that this product must store in a cool and dry place, protected from light and ozone.Instruction mention check the system for leakages.Without the actual device returned, the complaint could not be confirmed and a root cause could not be established.
Event or Problem Description
It was reported "there was an anesthesia stat in the or this week related to decreased etco2/circuit leak that occurred in the middle of a case that was ultimately traced to a small defect/crack in the corrugated extension tubing".Specific patient information unknown at time of reporting.

• 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: 12901678
• Report Number: 8040412-2021-00303
• Device Sequence Number: 17417014
• Product Code: BZO
• UDI-Device Identifier: 04026704388769
• UDI-Public: 04026704388769
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2021

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
• 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: 11/05/2021
• Supplement Date Received by Manufacturer: 12/27/2021
• Initial Report FDA Received Date: 11/30/2021
• Supplement Report FDA Received Date: 12/27/2021
• 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