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 NEBULIZER ADAPTOR 033,STERILE,JAPANESE; NEBULIZER (DIRECT PATIENT INTE
  • 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 NEBULIZER ADAPTOR 033,STERILE,JAPANESE; NEBULIZER (DIRECT PATIENT INTE Back to Search Results
Catalog Number 031-33J
Device Problem Connection Problem (2900)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/10/2017
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 received 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 relate to this complaint.The dhr shows that the product was assembled and inspected according to our specifications.Customer complaint cannot be confirmed based on the information received.It is necessary the physical sample in order to perform a proper and thorough investigation to confirm the alleged defect and determine a root cause.If the device sample becomes available this investigation will be updated with the evaluation results.The personnel of the assembly line were notified for awareness.
 
Event Description
Customer complaint alleges "it was reported that during product prep before use, the nebulizer adapter could not be attached to the oxygen flow meter as the connecting part did not fit properly.As a result, a new kit was used instead".There was no report of patient injury or consequence.
 
Manufacturer Narrative
(b)(4).The sample was returned for evaluation.A visual exam was performed and no issues were found.Functional testing was also performed and the sample passed the tests.During the setup of the oxygen entrainment testing, however, it was observed that the assembly of the nut adaptor and the upper body component was unstable.Even with that condition, the sample was able to be tested with no functional issues.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found and the sample functioned as intended.
 
Event Description
Customer complaint alleges "it was reported that during product prep before use, the nebulizer adapter could not be attached to the oxygen flow meter as the connecting part did not fit properly.As a result, a new kit was used instead".There was no report of patient injury or consequence.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE
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 Key7053425
MDR Text Key93258591
Report Number3004365956-2017-00415
Device Sequence Number1
Product Code CAF
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K153010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/13/2017
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 Date08/23/2021
Device Catalogue Number031-33J
Device Lot Number74H1602627
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/20/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/13/2017
Initial Date FDA Received11/22/2017
Supplement Dates Manufacturer Received01/19/2018
Supplement Dates FDA Received01/22/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/22/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-