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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE; NEBULIZER (DIRECT PATIENT INTE
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TELEFLEX MEDICAL HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE; NEBULIZER (DIRECT PATIENT INTE Back to Search Results
Catalog Number 031-33J
Device Problem Disconnection (1171)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/13/2018
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 has not been received by the manufacturer at the time of this report.The device history record (dhr) has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.Dhr shows that the product was assembled and inspected according to our specifications.Customer complaint cannot be confirmed due the lack of product sample to perform a proper investigation and determine the root cause.Root cause is unknown.If the sample becomes available this report will be updated with the evaluation results.
 
Event Description
Customer complaint alleges "the connection part assembly to the flowmeter was unstably attached to the adaptor, and fell out".Therefore, a new unit was used instead.Alleged issue reported as occurred during patient use.No patient injury was reported.The patient condition was reported as "fine".
 
Manufacturer Narrative
(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the adaptor was missing.It was not possible to perform the oxygen entrainment testing due to the missing component.As additional testing purposes, one component part number tfx-001743.(adaptor, snap-on flowmeter resin re-0042) was taken from the assembly line and assembled on the sample.After that, the sample was tested on the oxygen entrainment testing.During the testing no issues or discrepancies were found that can lead to the condition reported by the customer.The complaint could not be confirmed and a root cause was not established as the sample was received with a missing component.
 
Event Description
Customer complaint alleges "the connection part assembly to the flowmeter was unstably attached to the adaptor, and fell out".Therefore, a new unit was used instead.Alleged issue reported as occurred during patient use.No patient injury was reported.The patient condition was reported as "fine".
 
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Brand Name
HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE
Type of Device
NEBULIZER (DIRECT PATIENT INTE
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
MDR Report Key7629509
MDR Text Key112038615
Report Number3004365956-2018-00204
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 06/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date08/17/2022
Device Catalogue Number031-33J
Device Lot Number74H1701585
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/16/2018
Date Manufacturer Received08/01/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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