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

Model Number IPN043768

Device Problem Gas/Air Leak (2946)

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

Event Date 04/19/2021

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

It was reported that "during the pre-test, alert leakage".No patient involvement reported.

Event Description

It was reported that "during the pre-test, alert leakage".No patient involvement reported.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.The customer did provide a video for evaluation.Based on the video, it was observed that bubbles were coming out from the filter, however further investigation could not be conducted to identify the root cause of leak.In the current manufacturing procedure, 100% visual inspection and leak testing is conducted after the assembly process; therefore, any defects would be detected prior to release from the manufacturing facility.A device history record review was performed and no relevant findings were identified.Without the actual device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the a vailable information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: HUDSON HUMID-VENT FILTER COMPACT STRAIGHT
• Type of Device: FILTER, BACTERIAL, BREATHING-C
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 11794353
• MDR Text Key: 252177592
• Report Number: 8040412-2021-00131
• Device Sequence Number: 1
• Product Code: CAH
• UDI-Device Identifier: 04026704348022
• UDI-Public: 04026704348022
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/21/2021

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
• Device Operator: No Information
• Device Model Number: IPN043768
• Device Catalogue Number: 19402
• Device Lot Number: KMZ20K0224
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/21/2021
• Initial Date FDA Received: 05/07/2021
• Supplement Dates Manufacturer Received: 06/10/2021
• Supplement Dates FDA Received: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1