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	01/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "during a facelift procedure it was noticed that the end of the flex tube had become torn.Due to this, it was necessary to manually bag the patient and switch the flex tube with a different lot number.The patient desaturated briefly during the procedure".Additional information provided stated that patient desaturated "5-6 points", no baseline information provided.No patient injury or harm reported.Patient condition is reported to be "100%".
Additional Manufacturer Narrative
Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The manufacturing site reports a 100% visual inspection and leak testing is conducted; therefore, any defects would be detected prior to release from the manufacturing facility.A device history record review was performed and no relevant findings were identified.The instructions for use (ifu) for this product mentions that the product must be stored in a cool and dry place protected from light and ozone.In addition, the product must not be used with flammable anaesthetics.The ifu also mentions to check the system for leakages.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 "during a facelift procedure it was noticed that the end of the flex tube had become torn.Due to this, it was necessary to manually bag the patient and switch the flex tube with a different lot number.The patient desaturated briefly during the procedure".Additional information provided stated that patient desaturated "5-6 points", no baseline information provided.No patient injury or harm reported.Patient condition is reported to be "100%".

• 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: 13569535
• Report Number: 8040412-2022-00042
• Device Sequence Number: 6062725
• Product Code: BZO
• UDI-Device Identifier: 04026704388769
• UDI-Public: 04026704388769
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/26/2022

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: 05/28/2026
• Device Model Number: IPN043837
• Device Catalogue Number: 20011
• Device Lot Number: KMH21F0412
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2022
• Supplement Date Received by Manufacturer: 03/10/2022
• Initial Report FDA Received Date: 02/21/2022
• Supplement Report FDA Received Date: 03/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2021
• 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