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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEBULIZER ADAPTOR 028,STERILE,SHELFPAK,; NEBULIZER (DIRECT PATIENT INTE
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TELEFLEX MEDICAL HUDSON NEBULIZER ADAPTOR 028,STERILE,SHELFPAK,; NEBULIZER (DIRECT PATIENT INTE Back to Search Results
Catalog Number 031-28J
Device Problem Fitting Problem (2183)
Patient Problem No Patient Involvement (2645)
Event Date 03/12/2018
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 could not be conducted as the lot number was unknown.Customer complaint cannot be confirmed based only on the information received.It is necessary to have the physical sample in order to perform a proper and thorough investigation to confirm the alleged defect and determine a root cause.If the sample becomes available this investigation will be updated with the evaluation results.
 
Event Description
Customer complaint alleges "that a user tried to tighten nut adapter, but it did not fit flow meter.Then, the adapter was unable to be attached to flow meter.As a result, a new kit was opened to be used." there was no report of patient involvement.
 
Manufacturer Narrative
(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that there was damage on the internal thread of the adaptor and it did not spin freely.No other damage was 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 was confirmed.Although the condition observed on the sample provided, there is not sufficient evidence to assure that this issue was originated during the manufacturing assembly or molding process.The damage found on the adaptor was most likely caused by the end user during the connection of the adaptor into the flowmeter.However, the personnel of the assembly line were notified on jun-13-2018 for awareness.Based on the investigation performed, the reported complaint was confirmed.Although the condition observed on the sample provided, there is not sufficient evidence to assure that this issue was originated during the manufacturing assembly or molding process.The wear on the internal tabs of the component was most likely caused by the end user during the connection of the adaptor into the flowmeter that causes an unstable connection.Personnel of the assembly line were notified on feb-06-2018 for awareness.
 
Event Description
Customer complaint alleges "that a user tried to tighten nut adapter, but it did not fit flow meter.Then, the adapter was unable to be attached to flow meter.As a result, a new kit was opened to be used." there was no report of patient involvement.
 
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Brand Name
HUDSON NEBULIZER ADAPTOR 028,STERILE,SHELFPAK,
Type of Device
NEBULIZER (DIRECT PATIENT INTE
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
MDR Report Key7352799
MDR Text Key102887677
Report Number3004365956-2018-00080
Device Sequence Number1
Product Code CAF
Combination Product (y/n)N
PMA/PMN Number
K153010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/12/2018
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 Catalogue Number031-28J
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/21/2018
Initial Date Manufacturer Received 03/12/2018
Initial Date FDA Received03/20/2018
Supplement Dates Manufacturer Received06/15/2018
Supplement Dates FDA Received06/18/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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