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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. HUDSON TRACH-VENT ,STERILE; CONDENSER, HEAT AND MOISTURE
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TELEFLEX MEDICAL SDN. BHD. HUDSON TRACH-VENT ,STERILE; CONDENSER, HEAT AND MOISTURE Back to Search Results
Model Number IPN044416
Device Problem Fitting Problem (2183)
Patient Problem Aspiration/Inhalation (1725)
Event Date 06/30/2021
Event Type  malfunction  
Manufacturer Narrative
Qn(b)(4).
 
Event Description
It was reported that: "during multiple aspirations during use on a patient, the secretions came out from all sides of the device but especially through the side paper filters".No patient injury or harm reported.Patient condition reported as "fine".
 
Event Description
It was reported that: "during multiple aspirations during use on a patient, the secretions came out from all sides of the device but especially through the side paper filters".No patient injury or harm reported.Patient condition reported as "fine".
 
Manufacturer Narrative
Qn# (b)(4).Ten representative samples were returned by the customer and sent to the manufacturing site for investigation.The manufacturing site reports: 10 pieces of representative sample were received.The samples were closely examined by visual inspection and no issues were found.It was also reported "from the description, it seems that the secretions found on the filter may caused by the accumulation of secretion from patient after usage.Ifu stated that replace device 24 hours or as needed to prevent accumulation of secretion.Replace unit immediately if soiled with secretion or otherwise obstructed.Besides that, trach vent should not be used with patients producing fulminating frothy secretions within their airways, or patients with haemoptysis.In current manufacturing procedure, visual inspection during assembly process at assembly area is conducted.Thus, any ineffective products will be culled out during this process.Furthermore, there is no material and process change since the product validated." a device history record review was performed and no relevant findings were identified.Based on the investigation performed, the reported complaint could not be confirmed.The actual device was not returned and there were no issues found with the returned representative samples.
 
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Brand Name
HUDSON TRACH-VENT ,STERILE
Type of Device
CONDENSER, HEAT AND MOISTURE
Manufacturer (Section D)
TELEFLEX MEDICAL SDN. BHD.
perak, west malaysia
MDR Report Key12235099
MDR Text Key264741150
Report Number8040412-2021-00204
Device Sequence Number1
Product Code BYD
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberIPN044416
Device Catalogue Number41311
Device Lot NumberKMH20J0231
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2021
Date Manufacturer Received08/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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