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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).
 
Event Description
It was reported that the adaptor is not fitting the flowmeter.No patient involvement.
 
Manufacturer Narrative
Qn#(b)(4).The sample was returned for evaluation.The product was received without the snap-on adaptor.A visual exam was performed and no issues were observed.Functional testing could not be performed as the complete sample was not returned.Based on the investigation performed, the reported complaint could not be confirmed.The complete device is needed to perform a proper investigation and to determine a root cause.
 
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 Key8795385
MDR Text Key151196131
Report Number3004365956-2019-00191
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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