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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 Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/27/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4) a visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device or a picture of the alleged defect was not provided at the time of this report.A device history record review could not be conducted since the lot number was not provided.It is necessary the physical sample in order to perform a proper and thorough investigation.Customer complaint cannot be confirmed based only on the information received.Root cause is unknown.Corrective actions cannot be established at this time.If the sample becomes available this investigation will be updated with the evaluation results.
 
Event Description
Customer complaint alleges "it was reported that water was leaking from the connection area between the adaptor and bottle.Therefore, a new unit was used instead." alleged defect reported as detected during use.There was no patient injury reported.Patient condition reported as "fine".
 
Event Description
Customer complaint alleges "it was reported that water was leaking from the connection area between the adaptor and bottle.Therefore, a new unit was used instead." alleged defect reported as detected during use.There was no patient injury reported.Patient condition reported as "fine".
 
Manufacturer Narrative
(b)(4).The sample was returned for evaluation.A visual exam was performed and no defects were observed.Functional testing was also performed and no issues were found.As an additional test, the sample was assembled with a new sterile water concha mini bottle and oxygen entrainment testing was performed.No functional issues were found during testing.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the reported complaint.
 
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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 Key7321655
MDR Text Key101972531
Report Number3004365956-2018-00071
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 02/27/2018
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 Catalogue Number031-33J
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/21/2018
Initial Date Manufacturer Received 02/27/2018
Initial Date FDA Received03/07/2018
Supplement Dates Manufacturer Received04/11/2018
Supplement Dates FDA Received04/16/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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