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

Model Number IPN043834

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event 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".

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 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
• Type of Device: 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
• MDR Text Key: 284311906
• Report Number: 8040412-2022-00001
• Device Sequence Number: 1
• Product Code: BYD
• UDI-Device Identifier: 04026704388745
• UDI-Public: 04026704388745
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K881657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 12/09/2021
• Initial Date FDA Received: 01/04/2022
• Supplement Dates Manufacturer Received: 01/27/2022
• Supplement Dates FDA Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1