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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ADAPTOR,028 NEB,INTL; NEBULIZER (DIRECT PATIENT INTE
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TELEFLEX MEDICAL HUDSON ADAPTOR,028 NEB,INTL; NEBULIZER (DIRECT PATIENT INTE Back to Search Results
Catalog Number 403128
Device Problem Fitting Problem (2183)
Patient Problem No Patient Involvement (2645)
Event Date 05/07/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
 
Event Description
It was reported that the adaptor is not fitting the flowmeter.No patient involvement.
 
Manufacturer Narrative
(b)(4).The sample was returned for evaluation.A visual exam was performed and no issues were observed.Functional testing was also performed and no issues were found.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned device.
 
Event Description
It was reported that the adaptor is not fitting the flowmeter.No patient involvement.
 
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Brand Name
HUDSON ADAPTOR,028 NEB,INTL
Type of Device
NEBULIZER (DIRECT PATIENT INTE
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
MDR Report Key8795616
MDR Text Key151202954
Report Number3004365956-2019-00192
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,distri
Type of Report Initial,Followup
Report Date 06/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number403128
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/31/2019
Date Manufacturer Received08/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
FLOW METER; FLOW METER; FLOW METER
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