MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. HUDSON HUMID-VENT FILTER COMPACT S, TETHERED C; FILTER, BACTERIAL, BREATHING-C

Model Number IPN043770

Device Problem Partial Blockage (1065)

Patient Problem Insufficient Information (4580)

Event Date 01/07/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that: "there was a blockage at the level of the filter, but filter was not occluded".Patient condition unknown at time of report.Attempts for additional information requested to the customer has been unsuccessful.

Event Description

It was reported that: "there was a blockage at the level of the filter, but filter was not occluded".Patient condition unknown at time of report.Attempts for additional information requested to the customer has been unsuccessful.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.The manufacturing facility reports that in the current manufacturing procedure 100% visual inspection, drop test (by sampling) and 100% leak test inspection after the assembly process is conducted; thus, any defective product would be detected prior to release.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.

• Brand Name: HUDSON HUMID-VENT FILTER COMPACT S, TETHERED C
• Type of Device: FILTER, BACTERIAL, BREATHING-C
• 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: 13444734
• MDR Text Key: 289352726
• Report Number: 8040412-2022-00020
• Device Sequence Number: 1
• Product Code: CAH
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: IPN043770
• Device Catalogue Number: 19402T
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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