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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE
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TELEFLEX MEDICAL HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE Back to Search Results
Catalog Number 031-33J
Device Problem Fitting Problem (2183)
Patient Problem No Patient Involvement (2645)
Event Date 11/24/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).A visual, functional, and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.No photo available for review.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 facility nor is being manufactured at the time.A device history record review could not be conducted since the lot number was not provided.No conclusion can be established at this time based on the lack of device sample.Customer complaint cannot be confirmed due to the lack of device sample to perform a proper investigation and determine the root cause.If the sample becomes available this investigation will be updated with the evaluation results.The personnel of the assembly line will be notified for awareness.
 
Event Description
The customer alleges that the connection between the adaptor and oxygen flowmeter was unstable so the aquapak bottle, aquatherm, and adaptor fell from the flowmeter.The alleged issue occurred prior to use.
 
Manufacturer Narrative
(b)(4).A visual inspection was conducted on the returned sample.Functional testing (oxygen entrainment testing) could not be performed due to missing component from the assembly.General pull and push test procedures were performed.Attempts to duplicate failure mode were performed.There are two ways to duplicate the failure mode of the loose or missing component (b)(4) from the assembly (by overtighten the nut adaptor onto the flow meter and by manipulating the assembly connection).However during testing, no observation of wear or damages on component (b)(4) was noted.A dhr review could not be conducted since the lot number was not provided.Customer complaint cannot be confirmed, since the sample was received without p/n (b)(4).Therefore, there is no sufficient evidence to assure this issue was originated during the manufacturing assembly process.The root cause for the condition reported could not be identified.However, the personnel from the adaptor assembly line were notified on (b)(6) 2017 for awareness.
 
Event Description
The customer alleges that the connection between the adaptor and oxygen flowmeter was unstable so the aquapak bottle, aquatherm, and adaptor fell from the flowmeter.The alleged issue occurred prior to use.
 
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Brand Name
HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE
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
margie burton, rn
3015 carrington mill blvd
morrisville, NC 27560
9194334965
MDR Report Key6169065
MDR Text Key62232312
Report Number3004365956-2016-00455
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,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/06/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number031-33J
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/18/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/06/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
OXYGEN FLOWMETERAQUATHERM
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