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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. HUDSON TRACH-VENT+,CLEAN; CONDENSER, HEAT AND MOISTURE
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TELEFLEX MEDICAL SDN. BHD. HUDSON TRACH-VENT+,CLEAN; CONDENSER, HEAT AND MOISTURE Back to Search Results
Catalog Number G41312
Device Problem Disconnection (1171)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/13/2022
Event Type  malfunction  
Event Description
It was reported that "the user found it difficult to connect the trach-vent to the cannula firmly during use.The trach-vent got dis connected from the cannula, therefore, it was replaced with a new kit." no patient injury, consequence, or harm reported.Patient condition reported as "fine".
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
(b)(4).The sample was returned by the customer and sent to the manufacturing site for investigation.The manufacturing site reports that a visual exam was performed, and no issues were observed.It was also reported that "based on the returned sample provided, 15mm plug gauge test was conducted on the connector of the sample.The connector side is in the specification according to iso 5356-1:2015.In current manufacturing procedure, iqc department will conduct sampling gauge test before release the part item to production.In production, 100% visual inspection at assembly area is conducted.Thus, any ineffective products will be culled out during this process.Therefore, it is very unlikely condition at the manufacturing area that the product having defect to be released for shipment." a device history record review was performed and no relevant findings were identified.The complaint could not be confirmed as no issues were found with the returned device.The sample was found to be within specification.
 
Event Description
It was reported that "the user found it difficult to connect the trach-vent to the cannula firmly during use.The trach-vent got dis connected from the cannula, therefore, it was replaced with a new kit." no patient injury, consequence, or harm reported.Patient condition reported as "fine".
 
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Brand Name
HUDSON TRACH-VENT+,CLEAN
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 Key15737970
MDR Text Key304627698
Report Number8040412-2022-00294
Device Sequence Number1
Product Code BYD
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative,Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberG41312
Device Lot NumberKMZ21B1072
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/03/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received12/01/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/26/2021
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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