MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. HUDSON SO-GARD FILTER,STRAIGHT; CONDENSER, HEAT AND MOISTURE (

Catalog Number 19212

Device Problem Material Separation (1562)

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

Event Date 11/24/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Mdr report key/report number (b)(4).

Event Description

Complaint from (b)(4) database: it was reported "ventilated patient on bipap system was being prepped for transport and the isogard filter came apart.Staff member was able to quickly press the two sections back together and it functioned properly afterward.".No patient harm or injury reported.Patient condition not reported.

Manufacturer Narrative

(b)(4).The sample was not returned for evaluation; therefore, ten pieces of the same product code were selected from current production at the manufacturing facility.The samples were visually inspected and no defects were observed.In addition to the visual exam, leak testing and pull testing were also performed on the production samples.No issues were encountered.All ten samples passed the testing.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 Description

Complaint from maude database: it was reported "ventilated patient on bipap system was being prepped for transport and the isogard filter came apart.Staff member was able to quickly press the two sections back together and it functioned properly afterward.".No patient harm or injury reported.Patient condition not reported.

• Brand Name: HUDSON SO-GARD FILTER,STRAIGHT
• Type of Device: CONDENSER, HEAT AND MOISTURE (
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 11151326
• MDR Text Key: 226318930
• Report Number: 8040412-2021-00008
• Device Sequence Number: 1
• Product Code: BYD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 12/16/2020

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: No Information
• Device Catalogue Number: 19212
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 01/11/2021
• Supplement Dates Manufacturer Received: 02/01/2021
• Supplement Dates FDA Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: N/A.; N/A.