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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 Consequences Or Impact To Patient (2199)
Event Date 04/22/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The complaint is reported as: "we tried to connect the adapter to the patient but not fastened the flow meter.If another adapter is replaced, it will be properly fastened.Only the adapter is considered defective." the patient condition is reported as "fine".
 
Manufacturer Narrative
(b)(4).One (1) unit of 403128 "adaptor,028 neb,intl" was received for analysis.A visual exam was performed and no defects were observed.The sample was tested on oxygen entrainment test and during the setup it was observed that the assembly of the nut adaptor component and the upper body component was unstable.Even with that condition, the sample was able to be tested on oxygen entrainment testing but the testing failed due to the condition.After the testing finished, the adaptor was carefully disassembled from the component upper body and it was visually inspected.During the visual inspection it was found wear on its internal tabs.Based on the additional inspection on the adaptor of the sample received, the complaint is 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 is most likely be caused by the end user during the connection of the adaptor into the flowmeter that causes an unstable connection issue.
 
Event Description
The complaint is reported as: "we tried to connect the adapter to the patient but not fastened the flow meter.If another adapter is replaced, it will be properly fastened.Only the adapter is considered defective." the patient condition is reported as "fine".
 
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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 Key8624793
MDR Text Key145534920
Report Number3004365956-2019-00120
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 04/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number403128
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/06/2019
Date Manufacturer Received05/31/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NOT REPORTED.; NOT REPORTED.; NOT REPORTED.
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