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

Model Number IPN041365

Device Problem Complete Blockage (1094)

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

Event Date 08/01/2023

Event Type  malfunction  

Event Description

It was reported that "teleflex filter had occluded at the sample port due to a thin plastic disc (presumably left over from the manufacturing process) which has then blocked gas from entering the sample line and therefore did not display c02/sevo etc values/waveforms on the anesthetic machine".As a result, the device was switched for another.No patient harm or injury.The patient status is reported as "fine".

Manufacturer Narrative

Qn#(b)(4).

Event Description

It was reported that "teleflex filter had occluded at the sample port due to a thin plastic disc (presumably left over from the manufacturing process) which has then blocked gas from entering the sample line and therefore did not display c02/sevo etc values/waveforms on the anesthetic machine".As a result, the device was switched for another.No patient harm or injury.The patient status is reported as "fine".

Manufacturer Narrative

(b)(4).The reported complaint of " co2 cap occluded" was not confirmed.One sample was returned for analysis.No abnormality was found on the product.Based on the investigation conducted on the returned sample, there is no occluded found on sample port of device.This complaint is not confirmed since there is no occlusion inside the device.But there is similar complaint reported on the product defect.Hence supplier corrective action request (scar) and nc has been issued, root cause analysis and identified corrective actions will be implemented through this scar.Assembly process will be conducted in our manufacturing site for the product after receive the part item from supplier.Based on the investigation conducted, this complaint is not confirmed since no defect found on the returned sample.There is complaint with similar defect has been reported.The mentioned product housing was supplied by our supplier, and hence supplier corrective action request (scar) and nc has been issued and root cause analysis and identified corrective actions wi ll be implemented through this scar.Teleflex will continue to monitor and trend on reports of this nature.

Manufacturer Narrative

(b)(4).Additional information provided from the customer: the customer was asked if the device was visually inspected prior to use.They responded that this issue would not be easily seen at all by visual inspection.They noted that the issue was observed right away as there was no co2 trace.The complaint sample was not returned.The customer provided photos for investigation.Based on the photo provided, the actual reported defect was not identified.Further investigation could not be conducted to identify the root cause of occluded on the complaint sample since there is no returned sample.A device history record review was performed, and no relevant findings were identified.An investigation was initiated to further investigate the issue.The investigation is still on-going.Based on the investigation, this complaint is not confirmed.

Event Description

It was reported that "teleflex filter had occluded at the sample port due to a thin plastic disc (presumably left over from the manufacturing process) which has then blocked gas from entering the sample line and therefore did not display c02/sevo etc values/waveforms on the anesthetic machine".As a result, the device was switched for another.No patient harm or injury.The patient status is reported as "fine".

• 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: 17673726
• MDR Text Key: 322543604
• Report Number: 8040412-2023-00337
• Device Sequence Number: 1
• Product Code: BYD
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 08/18/2023

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: Health Professional
• Device Model Number: IPN041365
• Device Catalogue Number: 11012T
• Device Lot Number: KMZ23A0453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/18/2023
• Initial Date FDA Received: 09/01/2023
• Supplement Dates Manufacturer Received: 10/06/2023; 11/01/2023
• Supplement Dates FDA Received: 10/16/2023; 11/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2023
• 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