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

Model Number	IPN042652
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem 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".
Additional 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 or Problem 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
• Common Device Name: FILTER, BACTERIAL, BREATHING-C
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 11333764
• Report Number: 8040412-2021-00029
• Device Sequence Number: 858648
• Product Code: CAH
• UDI-Device Identifier: 04026704399208
• UDI-Public: 04026704399208
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K961914
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2021

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: No Information
• Device Model Number: IPN042652
• Device Catalogue Number: 1605
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/26/2021
• Supplement Date Received by Manufacturer: 03/17/2021
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 03/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TRILOGY, V-60, AND LTV VENTS; TRILOGY, V-60, AND LTV VENTS; TRILOGY, V-60, AND LTV VENTS