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

Model Number IPN041365

Device Problem Fitting Problem (2183)

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

Event Date 11/23/2023

Event Type  malfunction  

Event Description

It was reported that: the external diameter of the antibacterial filter does not allow the anaesthesia mask to be properly attached.Patient ventilation difficult due to circuit disconnection.The filter was replaced, and the mask attached successfully.There were no negative consequences for the patient.

Manufacturer Narrative

Qn#: (b)(4).

Manufacturer Narrative

(b)(4).The sample was returned to the manufacturer for investigation.The manufacturer reported: "one actual sample was received.The sample was closely examined by visual inspection.No issue was found on the sample.Complaint reported that the external diameter of the antibacterial filter does not allow the anaesthesia mask to be properly attached.Based on the returned sample provided, 15 mm ring gauge test and 15mm plug gauge test were conducted on the connector of the samples.In current manufacturing procedure, iqc department will conduct gauge test before release the part item to production.In production, 100% visual inspection and leak testing at assembly area is conducted.Thus, any ineffective products will be culled out during this process.Therefore, it is unlikely condition at the manufacturing area that the product having defect to be released for shipment.Customer complained that circuit disconnection.But as per gauge tests conducted on returned sample, the connectors meet specification.Hence, this complaint could not be confirmed." teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that: the external diameter of the antibacterial filter does not allow the anaesthesia mask to be properly attached.Patient ventilation difficult due to circuit disconnection.The filter was replaced, and the mask attached successfully.There were no negative consequences for the patient.

• 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: 18355596
• MDR Text Key: 331190785
• Report Number: 8040412-2023-00408
• Device Sequence Number: 1
• Product Code: BYD
• 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: 11/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN041365
• Device Catalogue Number: 11012T
• Device Lot Number: 40Z23E3567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2023
• 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
• Treatment: NOT REPORTED; NOT REPORTED