MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. GIBECK HUMID-VENT FILTER LIGHT S; CONDENSER, HEAT AND MOISTURE (

Model Number	IPN043834
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "a therapist placed a new humid vent filter on a patient, heard rattling, removed and shook it with large amount of white particles flying everywhere".No patient injury or harm reported.Patient condition reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).The actual device was not returned; however, the customer provided a photo for evaluation.A visual exam was performed on the photo and it was observed there were white particles on the patient as mentioned in the complaint description.The actual device was not in the photo.It could not be determined where the white particles came from.The manufacturing site reports that a 100% visual inspection and leak testing is conducted after the assembly process; 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.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
It was reported "a therapist placed a new humid vent filter on a patient, heard rattling, removed and shook it with large amount of white particles flying everywhere".No patient injury or harm reported.Patient condition reported as "fine".

• Brand Name: GIBECK HUMID-VENT FILTER LIGHT S
• Common Device Name: CONDENSER, HEAT AND MOISTURE (
• 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: 13151122
• Report Number: 8040412-2022-00001
• Device Sequence Number: 20170543
• Product Code: BYD
• UDI-Device Identifier: 04026704388745
• UDI-Public: 04026704388745
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K881657
• 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): 12/09/2021

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
• Operator of Device: Health Professional
• Device Model Number: IPN043834
• Device Catalogue Number: 19932
• Device Lot Number: KMZ21B0684
• 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: 12/09/2021
• Supplement Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 01/04/2022
• Supplement Report FDA Received Date: 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2021
• 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