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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE; NEBULIZER (DIRECT PATIENT INTE
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TELEFLEX MEDICAL HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE; NEBULIZER (DIRECT PATIENT INTE Back to Search Results
Catalog Number 031-33J
Device Problem Disconnection (1171)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/19/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device involved or a picture of the alleged defect, was not received for evaluation by the manufacturer at the time of this report.The device history record of the lot number reported has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.It is necessary to have the physical sample in order to perform a proper investigation to confirm the alleged defect and determine a root cause.Customer complaint cannot be confirmed.Root cause is unknown.No corrective action can be assigned at this time.If the device becomes available this report will be updated with the evaluation results.
 
Event Description
Customer complaint alleges "the connector of the nebulizer adaptor detached from the adaptor while in use so the aquapak fell on the floor." alleged issue reported occurred during use.No patient injury was reported.Patient condition reported as fine.
 
Event Description
Customer complaint alleges "the connector of the nebulizer adaptor detached from the adaptor while in use so the aquapak fell on the floor." alleged issue reported occurred during use.No patient injury was reported.Patient condition reported as fine.
 
Manufacturer Narrative
(b)(4).The sample was returned for evaluation.During the visual inspection it was detected that the sample was received in its original package.The sample was tested on the oxygen entrainment test with no functional issues.As an additional test the sample was tested on the oxygen entrainment test using a bottle of sterile water connected to the nebulizer adaptor in order to simulating the use of the customer and no issues were detected.Based on the investigation performed, the reported complaint could not be confirmed.There were no issued found with the returned device.
 
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Brand Name
HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE
Type of Device
NEBULIZER (DIRECT PATIENT INTE
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
MDR Report Key8015664
MDR Text Key125459539
Report Number3004365956-2018-00325
Device Sequence Number1
Product Code CAF
Combination Product (y/n)N
PMA/PMN Number
K153010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 10/19/2018
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 No Information
Device Expiration Date11/10/2021
Device Catalogue Number031-33J
Device Lot Number74L1601445
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2018
Initial Date Manufacturer Received 10/19/2018
Initial Date FDA Received10/29/2018
Supplement Dates Manufacturer Received12/05/2018
Supplement Dates FDA Received12/06/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NONE REPORTED.; NONE REPORTED.
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