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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. HUMID VENT PEDI; CONDENSER, HEAT AND MOISTURE
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TELEFLEX MEDICAL SDN. BHD. HUMID VENT PEDI; CONDENSER, HEAT AND MOISTURE Back to Search Results
Model Number IPN041365
Device Problem Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/05/2023
Event Type  malfunction  
Event Description
It was reported that during use on a patient, "the cap was occluded by a plastic that unable us to monitor".Additional information states that there was no patient harm or injury as the issue was identified at the time of connection.The filter was changed out and the patient's current status is reported as "fine".
 
Manufacturer Narrative
Qn#(b)(4).Other remarks: n/a.Corrected data: n/a.
 
Manufacturer Narrative
(b)(4).The sample was returned and sent to the manufacturing site for investigation.The manufacturing site reports "complaint reported that cap area was occluded by a plastic.Based on the investigation conducted on the returned sample, luer port of the complaint product housing has occluded by the housing material.The mentioned product housing was supplied by our supplier, and 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.".
 
Event Description
It was reported that during use on a patient, "the cap was occluded by a plastic that unable us to monitor".Additional information states that there was no patient harm or injury as the issue was identified at the time of connection.The filter was changed out and the patient's current status is reported as "fine".
 
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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
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key17377272
MDR Text Key319784279
Report Number8040412-2023-00295
Device Sequence Number1
Product Code BYD
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
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 07/05/2023
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 NumberIPN041365
Device Catalogue Number11012T
Device Lot NumberKMZ23B0263
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/05/2023
Initial Date FDA Received07/24/2023
Supplement Dates Manufacturer Received08/24/2023
Supplement Dates FDA Received08/24/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/28/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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