MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. HUMID-VENT FILTER COMPACT STRAIGHT; FILTER, BACTERIAL, BREATHING-C

Catalog Number	19402
Medical Device Problem Code	Blocked Connection (2888)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	01/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "we had a bacterial filter fail on one of our anesthetic machines causing the patient to desaturate and drugs were given to the patient to no effect.On further investigation it was discovered that part of the paper filter was moving with the patient respirations.The filter was not wet.There may also have been a leak at the bottom of the co2 sampling port.Once the filter was replaced the patient's sats' returned to normal levels and the operation was completed without further issues".The patient status is reported as "fine".At the time of this report, the customer has not returned our requests for additional information.
Event or Problem Description
It was reported that "we had a bacterial filter fail on one of our anesthetic machines causing the patient to desaturate and drugs were given to the patient to no effect.On further investigation it was discovered that part of the paper filter was moving with the patient respirations.The filter was not wet.There may also have been a leak at the bottom of the co2 sampling port.Once the filter was replaced the patient's sats' returned to normal levels and the operation was completed without further issues".The patient status is reported as "fine".At the time of this report, the customer has not returned our requests for additional information.
Additional Manufacturer Narrative
Qn#(b)(4).Additional information received on 25 february 2025 states "yes the patient desaturated.Remedied once filter changed".No medical intervention needed.The sample was returned to the manufacturer for evaluation.The manufacturer reported: "one sample was received.Visual inspection was conducted on the actual sample.Complaint reported that paper filter was moving with the patient respirations.The filter was not wet.There may also have been a leak at the bottom of the co2 sampling port.Based on the investigation conducted on the returned sample, the sample was assembled correctly and no blockage found on the housing.Record shows there is no material change for this product code.In current manufacturing procedure, 100% visual inspection, 100% leak test and drop test sampling after assembly process are conducted.Thus, any ineffective products will be culled out during the inspection and testing.No similar defect found at manufacturing site.Therefore, it is very unlikely condition at the manufacturing area that the product having defect to be released for shipment.This is meeting the visual manufacturing released specifications.Functional inspection was performed, the sample was undergone leak test.No leak observed on the returned sample.This is meeting the manufacturing released specifications.The device history record for lot 40z24f1872 was reviewed and no issue related to complaint was noted.The device was manufactured according to release specification.Based on the investigation conducted, the returned sample does not have any defect, and it is meeting manufacturing release criteria.The complaint could not be verified as manufacturing related issue." teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: HUMID-VENT FILTER COMPACT STRAIGHT
• Common Device Name: FILTER, BACTERIAL, BREATHING-C
• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21423458
• Report Number: 8040412-2025-00055
• Device Sequence Number: 12660399
• Product Code: CAH
• UDI-Device Identifier: 04026704348022
• UDI-Public: (01)04026704348022(11)240611(17)290531(10)40Z24F1872(21)
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K964382
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 19402
• Device Lot Number: 40Z24F1872
• 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: 01/28/2025
• Supplement Date Received by Manufacturer: 03/18/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2024
• 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