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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEBULIZER ADAPTOR 028,SHELFPAK
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TELEFLEX MEDICAL HUDSON NEBULIZER ADAPTOR 028,SHELFPAK Back to Search Results
Catalog Number 031-28J
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/23/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).A visual inspection of the product involved in the complaint could not be conducted since the product or a picture of the defect was not provided by the customer.An attempt to inspect current stock of material was made but at the time there is no inventory of the involved product code available at the manufacturing facility.The device history record (dhr) of the product 031-28j , batch number 74d1500871 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No nonconformance reports were originated for the lot in question that can be associated to the reported complaint.All materials used during the assembly met current specifications.The dhr shows that the product was assembled and inspected according to our specifications.Customer complaint cannot be confirmed due the lack of product sample to perform a proper investigation and determine the root cause.If the sample becomes available this complaint will be updated with the evaluation results.Personnel of the assembly line were notified on mar-29-2017 for awareness.
 
Event Description
The complaint is reported as: "during use, back-flow of air was confirmed with bubbling in the bottom of the bottle.Therefore, a new unit was used instead." there was no report of patient injury or harm.
 
Manufacturer Narrative
(b)(4).The sample was returned for evaluation.A visual exam was performed and no defects were observed.Functional testing was performed and no issues were encountered during the oxygen entrainment test and the general pull and push test.The sample failed the station lift test.The sample was then assembled with a sterile water concha mini bottle and the oxygen entrainment test was performed; however, the testing failed as the water from the bottle never went to the adapter, it was only bubbling in the bottle.Based on the investigation performed, the reported complaint of "back flow of air" was confirmed.A meeting was held with the molding personnel at the manufacturing facility , and a non-conformance was initiated to address the root cause and action plan.In addition , personnel on the assembly line were made aware of this issue.
 
Event Description
The complaint is reported as: "during use, back-flow of air was confirmed with bubbling in the bottom of the bottle.Therefore, a new unit was used instead." there was no report of patient injury or harm.
 
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Brand Name
HUDSON NEBULIZER ADAPTOR 028,SHELFPAK
Type of Device
NEBULIZER ADAPTOR
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 Key6481657
MDR Text Key72511645
Report Number3004365956-2017-00120
Device Sequence Number1
Product Code CAF
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/08/2020
Device Catalogue Number031-28J
Device Lot Number74D1500871
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/27/2017
Is the Reporter a Health Professional? No
Date Manufacturer Received05/24/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/07/2015
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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