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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 Disconnection (1171)
Patient Problems No Consequences Or Impact To Patient (2199); Anxiety (2328)
Event Date 05/15/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device involved in this complaint has been returned to the manufacturer, however the investigation of said device is still in progress at the time of this report.A device history record review shows that the product was assembled and inspected according to our specifications.This report will be updated at the conclusion of the device evaluation.
 
Event Description
Customer complaint alleges " on (b)(6) 2017, in atomizing chamber of pediatric outpatient department, (b)(6), doctor found the tube was dropped off the connector".Alleged event reported as occurring during use.It was reported that the "child was frightened by this event".Patient condition reported as "fine".
 
Manufacturer Narrative
(b)(4).The sample was returned for evaluation.Visual inspection of the returned sample indicated that one of the connectors was not returned and was missing from the end of the tubing.Therefore, the reported complaint that the connector disconnected from the tubing was confirmed.A non-conformance was opened to address this issue.
 
Event Description
Customer complaint alleges " on (b)(6) 2017, in atomizing chamber of pediatric outpatient department, (b)(6), doctor found the tube was dropped off the connector".Alleged event reported as occurring during use.It was reported that the "child was frightened by this event".Patient condition reported as "fine".
 
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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
Manufacturer (Section G)
TELEFLEX MEDICAL
parque industrial finsa
nuevo laredo 88275
MX   88275
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key6618518
MDR Text Key76868184
Report Number3004365956-2017-00232
Device Sequence Number1
Product Code CAF
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K930525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number1886
Device Lot Number74J1600288
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/02/2017
Is the Reporter a Health Professional? No
Date Manufacturer Received06/16/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2016
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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