MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. HUDSON BACTERIAL/VIRAL FILTER; FILTER, BACTERIAL, BREATHING-C

Model Number IPN042652

Device Problem Disconnection (1171)

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

Event Date 01/25/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the "filter pops off ventilator during use on patients.Incidents occurred on trilogy, v-60, and ltv vents".No patient injurty or harm reported.Patient condition reported as "fine".

Manufacturer Narrative

Qn# (b)(4).The actual sample was not returned; therefore a representative sample was taken from production at the manufacturing site.A visual exam was performed on the representative sample and no defects were observed.In the current manufacturing procedure, 100% leak testing and visual inspection after the assembly process is conducted.Thus, any defects would be detected prior to release from the manufacturing facility.Without the actual 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

It was reported the "filter pops off ventilator during use on patients.Incidents occurred on trilogy, v-60, and ltv vents".No patient injurty or harm reported.Patient condition reported as "fine".

• Brand Name: HUDSON BACTERIAL/VIRAL FILTER
• Type of Device: FILTER, BACTERIAL, BREATHING-C
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 11333764
• MDR Text Key: 232082613
• Report Number: 8040412-2021-00029
• Device Sequence Number: 1
• Product Code: CAH
• UDI-Device Identifier: 04026704399208
• UDI-Public: 04026704399208
• Combination Product (y/n): N
• PMA/PMN Number: K961914
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: IPN042652
• Device Catalogue Number: 1605
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TRILOGY, V-60, AND LTV VENTS; TRILOGY, V-60, AND LTV VENTS; TRILOGY, V-60, AND LTV VENTS