Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ISO-NEB FILTERED NEBULIZER SYSTEM; NEBULIZER, MEDICINAL,NON-VENTILATORY
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TELEFLEX MEDICAL HUDSON ISO-NEB FILTERED NEBULIZER SYSTEM; NEBULIZER, MEDICINAL,NON-VENTILATORY Back to Search Results
Catalog Number 1755
Device Problem Failure to Deliver (2338)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 05/04/2017
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 shows that the device was assembled and inspected according to our specifications.Customer complaint cannot be confirmed based only on the information provided, to perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved on this complaint.However material from our current inventory was functionally inspected and no issues were detected that can lead this customer complaint.Regarding similar complaints from this same issue a capa (b)(4) was generated in order to further investigate this issue.If the device sample becomes available at a later date this complaint will be updated.
 
Event Description
Customer complaint alleges that the staff reports the device with this lot number is defective.Customer alleges the device was tested, and "the neb just bubbled".Alleged malfunction reported as detected during pre-testing.No report of patient involvement.No report of patient harm or delay in treatment.
 
Manufacturer Narrative
(b)(4).The sample was returned for evaluation.The jet and jar were microscopically inspected and no defects or anomalies were observed.The remaining components were visually inspected and no defects or anomalies were observed.Functional testing was performed and 5cc of water was added to the returned nebulizer unit and the returned tubing was connected to an air flowmeter and the pressure was increased to 8lpm.A mist was produced from the chamber of the nebulizer and bubbling could not be confirmed.There were no functional issues found with the returned sample.The reported complaint of the nebulizer bubbled prior to used could not be confirmed through visual or functional inspection of the returned sample.The investigation of the returned sample found no evidence to suggest a manufacturing related cause as no functional issues were found with the returned sample.
 
Event Description
Customer complaint alleges that the staff reports the device with this lot number is defective.Customer alleges the device was tested, and "the neb just bubbled".Alleged malfunction reported as detected during pre-testing.No report of patient involvement.No report of patient harm or delay in treatment.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HUDSON ISO-NEB FILTERED NEBULIZER SYSTEM
Type of Device
NEBULIZER, MEDICINAL,NON-VENTILATORY
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 Key6587026
MDR Text Key75824992
Report Number3004365956-2017-00211
Device Sequence Number1
Product Code CCQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other
Remedial Action Other
Type of Report Initial,Followup
Report Date 05/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date02/20/2022
Device Catalogue Number1755
Device Lot Number74B1702078
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2017
Is the Reporter a Health Professional? No
Date Manufacturer Received07/06/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/15/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-