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	Low Oxygen Saturation (2477)
Date of Event	11/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "corrugated extension used to connect anesthesia circuit to endotracheal tube.During case, there was loss of etco2 and patient briefly desaturated prior to the discovery of a tear in this connector".No patient injury or harm reported.No further information provided on patient condition.
Additional Manufacturer Narrative
Qn# (b)(4).
Additional Manufacturer Narrative
Qn# (b)(4).The sample was returned by the customer for investigation.A visual exam was performed and it was found that the tubing was torn.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.In ifu for this product mentions to store in a cool and dry place, protected from light and ozone.In addition, the product must not be used with flammable anesthetics.The ifu also mentions to check the system for leakages.A device history record review was performed and no relevant findings were identified.The complaint has been confirmed.A non-conformance was opened to further investigate this issue.
Event or Problem Description
It was reported "corrugated extension used to connect anesthesia circuit to endotracheal tube.During case, there was loss of etco2 and patient briefly desaturated prior to the discovery of a tear in this connector".No patient injury or harm reported.No further information provided on patient condition.

• 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: 12924220
• Report Number: 8040412-2021-00313
• Device Sequence Number: 5615607
• Product Code: BZO
• UDI-Device Identifier: 04026704388769
• UDI-Public: 04026704388769
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 11/15/2021

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 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: 12/06/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2021
• Supplement Date Received by Manufacturer: 03/10/2022
• Initial Report FDA Received Date: 12/03/2021
• Supplement Report FDA Received Date: 03/10/2022
• 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