MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. HUMID VENT PEDI; CONDENSER, HEAT AND MOISTURE

Catalog Number 11012T

Device Problem Defective Device (2588)

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

Event Date 09/21/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that prior to use "according to the hcp the filters were closed and could not be used.The hospital staff tried to insert a needle and pump or inject air and there was no change".No patient involvement.

Manufacturer Narrative

(b)(4).There was no sample returned to the manufacturing site for investigation.However, the customer did provided photos.The manufacturing site reports "a full investigation on the reported failure could not be conducted to identify the actual root cause of the reported phenomenon.Therefore, this complaint is not confirmed.A device history record review was performed, and no relevant findings were identified." teleflex will continue to monitor and trend on reports of this nature.

Event Description

It was reported that prior to use "according to the hcp the filters were closed and could not be used.The hospital staff tried to insert a needle and pump or inject air and there was no change".No patient involvement.

• Brand Name: HUMID VENT PEDI
• Type of Device: CONDENSER, HEAT AND MOISTURE
• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17920771
• MDR Text Key: 325499408
• Report Number: 8040412-2023-00371
• Device Sequence Number: 1
• Product Code: BYD
• Combination Product (y/n): N
• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 11012T
• Device Lot Number: KMZ22M0339
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2023
• 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