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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON MICRO MIST NEBULIZER W/ELONG; NEBULIZER (DIRECT PATIENT INTE
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TELEFLEX MEDICAL HUDSON MICRO MIST NEBULIZER W/ELONG; NEBULIZER (DIRECT PATIENT INTE Back to Search Results
Catalog Number 1886
Device Problem Failure to Deliver (2338)
Patient Problem No Patient Involvement (2645)
Event Date 06/17/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The complaint is reported as: "the patient is micro nebulized, in its micro nebulization number 4 the nebulizer does not fulfill its function".The issue was detected prior to use on a patient.No patient injury or consequence.
 
Event Description
The complaint is reported as: "the patient is micro nebulized, in its micro nebulization number 4 the nebulizer does not fulfill its function".The issue was detected prior to use on a patient.No patient injury or consequence.
 
Manufacturer Narrative
Qn#(b)(4).The customer reported that the nebulizer did not produce mist prior to use.The customer returned one sealed kit (representative sample) of catalog number 1886 micro mist nebulizer w/elong for analysis, lot 74b1800628.Returned components included a jet, jar, cap, mask, tubing and ifu.During the visual inspection, brown colored particulates were observed sitting inside of the cap and on the inside well of the cap.5cc of water was added to the returned nebulizer unit, the tubing was connected to an air flowmeter and the pressure was increased to 8 lpm.During the functional inspection, the nebulizer produced mist.The device history record of batch number 74b1800628 was reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No non-conformance reports were originated for the lot in question that can be associated to the complaint reported.The dhr shows that the product was assembled and inspected according to specifications.The reported complaint that the nebulizer did not produce mist was not confirmed through the functional inspection.During the functional testing, the nebulizer produced mist from the chamber of the nebulizer.However, because the actual sample was not returned, the root cause of this investigation is undetermined.
 
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Brand Name
HUDSON MICRO MIST NEBULIZER W/ELONG
Type of Device
NEBULIZER (DIRECT PATIENT INTE
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
MDR Report Key8787524
MDR Text Key150963316
Report Number3004365956-2019-00195
Device Sequence Number1
Product Code CAF
Combination Product (y/n)N
PMA/PMN Number
K930525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 06/19/2019
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 Date02/12/2023
Device Catalogue Number1886
Device Lot Number74B1800628
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/24/2019
Initial Date Manufacturer Received 06/19/2019
Initial Date FDA Received07/14/2019
Supplement Dates Manufacturer Received08/02/2019
Supplement Dates FDA Received08/07/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NOT REPORTED; NOT REPORTED
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