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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ADAPTOR,028 NEB,INTL; NEBULIZER
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TELEFLEX MEDICAL HUDSON ADAPTOR,028 NEB,INTL; NEBULIZER Back to Search Results
Catalog Number 403128
Device Problem Connection Problem (2900)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Date 11/01/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4) a visual and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.No photo available.No functional inspection can be performed since the device sample is not available for evaluation.(b)(4).
 
Event Description
The customer alleges that the adaptor does not fit properly to the flowmeter.It is difficult to screw onto the flowmeter.
 
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Brand Name
HUDSON ADAPTOR,028 NEB,INTL
Type of Device
NEBULIZER
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 Key5267178
MDR Text Key32678269
Report Number3004365956-2015-00380
Device Sequence Number1
Product Code CAF
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Remedial Action Other
Type of Report Initial
Report Date 11/19/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number403128
Device Lot Number74C1503064
Was Device Available for Evaluation? No
Date Manufacturer Received11/19/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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
FLOWMETER
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