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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ISO-NEB FILTERED NEBULIZER SYSTEM; NEBULIZER (DIRECT PATIENT INTE
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TELEFLEX MEDICAL HUDSON ISO-NEB FILTERED NEBULIZER SYSTEM; NEBULIZER (DIRECT PATIENT INTE Back to Search Results
Catalog Number 1755
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/30/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device involved has not been received for evaluation by the manufacturer at the time of this report.The device history record (dhr) has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint.Dhr shows that the product was assembled and inspected according to our specifications.To perform a proper and thorough investigation to determine the source of defect reported it is necessary to evaluate the sample involved.Customer complaint cannot be confirmed based only on the information provided.Root cause cannot be determined.If the sample becomes available this investigation will be updated with the evaluation results.
 
Event Description
Customer complaint alleges "it has been noticed that after the nebulizer treatment has started the solution leaks out of the nebulizer chamber." no patient harm reported.Patient condition reported as fine.
 
Manufacturer Narrative
(b)(4).The customer returned (1) one unit of catalog number 1755 iso-neb filtered nebulizer system for analysis.During the visual inspection, it was observed that a jet, jar, cap, tubing, bacteria filter, mouthpiece, two aerosol tees, two one-way valves, corrugated tubing, reduced hose end, and a female-to-male one way valve were received.The components were received assembled.During the visual inspection, it was observed that the nebulizer unit did not appear to be used and that there were no defects or anomalies.Functional testing was performed and no issues were encountered.The sample was found to be within specification.The reported complaint that the nebulizer leaked could not be confirmed.
 
Event Description
Customer complaint alleges "it has been noticed that after the nebulizer treatment has started the solution leaks out of the nebulizer chamber." no patient harm reported.Patient condition reported as fine.
 
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Brand Name
HUDSON ISO-NEB FILTERED NEBULIZER SYSTEM
Type of Device
NEBULIZER (DIRECT PATIENT INTE
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
MDR Report Key8325831
MDR Text Key137007091
Report Number3004365956-2019-00039
Device Sequence Number1
Product Code CAF
Combination Product (y/n)N
PMA/PMN Number
K895231
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 01/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date05/09/2023
Device Catalogue Number1755
Device Lot Number74E1801436
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/07/2019
Date Manufacturer Received03/08/2019
Patient Sequence Number1
Treatment
NONE REPORTED.; NONE REPORTED.
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