MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. HUDSON H-V FILTER COMPACT AND EXPANDI-FLEX,STE; HUMID-VENT FILTER

Catalog Number G19621

Device Problem Excess Flow or Over-Infusion (1311)

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

Event Date 10/28/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported "customer notified excess water, requiring frequent change at the time of use.In some cases, the filter has a dark coloration".It was reported that "some patients had a resistance to flow".However, customer unable to provide specifics to the event.Customer reported filters were replaced when malfunctioned.Patient condition reported as "fine".

Manufacturer Narrative

Qn#: (b)(4).The actual device was not returned for evaluation.The manufacturing site has performed a device history record on the lot number reported and no relevant findings were identified.The manufacturing site has reviewed the photos provided by the customer and has stated: "the actual reported defect was not identified.Further investigation could not be conducted to identify the defect on the complaint sample since there is no returned sample.The filter turns dark coloration may due to the contamination, excess water from secretion after usage.These defect happened also may due to improper usage on the device.There is no material change for the product manufactured.In current manufacturing procedure, visual inspection during assembly process, 100% leak test and sampling drop test at assembly area is conducted.Thus, any ineffective products will be culled out during this process." 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

It was reported "customer notified excess water, requiring frequent change at the time of use.In some cases, the filter has a dark coloration".It was reported that "some patients had a resistance to flow".However, customer unable to provide specifics to the event.Customer reported filters were replaced when malfunctioned.Patient condition reported as "fine".

• Brand Name: HUDSON H-V FILTER COMPACT AND EXPANDI-FLEX,STE
• Type of Device: HUMID-VENT FILTER
• 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: 12985355
• MDR Text Key: 282128347
• Report Number: 8040412-2021-00339
• Device Sequence Number: 1
• Product Code: CAH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: G19621
• Device Lot Number: 20BT48
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2020
• 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
• Treatment: N/A.; N/A.