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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 05/21/2018
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 defect was not provided at the time of this report.The device history record (dhr) of the device has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.All materials used during the assembly met current specifications.Dhr shows that the product was assembled and inspected according to our specifications.Customer complaint cannot be confirmed due the lack of device sample to perform a proper investigation and determine the root cause.If the sample becomes available this report will be updated with the evaluation results.
 
Event Description
Customer complaint alleges "water of the first aquapak bottle run out so the user replaced it with a second one.However, when connecting the second bottle to the adaptor, the connection was loose and the second bottle fell from the adaptor".It was reported no patient injury occurred.The patient condition was reported as "fine".
 
Event Description
Customer complaint alleges "water of the first aquapak bottle run out so the user replaced it with a second one.However, when connecting the second bottle to the adaptor, the connection was loose and the second bottle fell from the adaptor".It was reported no patient injury occurred.The patient condition was reported as "fine".
 
Manufacturer Narrative
(b)(4) one (1) unit ph12153 033 neb adaptor phantom holder, (subassembly is part of the fg 031-33j nebulizer adaptor 033, sterile, japanese related to this customer complaint), was received for analysis.Visual inspection found slight damage on the thread of component p/n tfx-001743 and such component doesn't spin freely.Sample was tested on the dual station lift test, and general pull and push test procedures with no functional issues.However, during the setup of the oxygen entrainment test, it was observed that the assembly of the nut adaptor component p/n tfx-001743 and the upper body component p/n mp-0527 was unstable.Even with that condition, the sample was able to be tested on oxygen entrainment testing with no functional issues.(continued) other remarks: as an additional test, with the unstable connection on the assembly, the sample was assembled with a sterile water 381-52 reservoir, concha mini 760 ml and tested according oxygen entrainment testing.Attempts to duplicate the failure mode were performed and there are two ways to duplicate them: the first one is by overtightening the nut adaptor p/n tfx-001743 into the flow meter.The second one is by manipulating the assembly connection.The complaint is confirmed.However, there is no sufficient evidence that this issue originated during the manufacturing assembly or molding process.The wear on the internal tabs of component is most likely caused by the end user during the assembly of the device/ connection to the flowmeter that causes an unstable connection.The personnel of the assembly line were notified on for awareness.Teleflex will continue to monitor customer feedback for complaints of this nature.
 
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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 Key7591298
MDR Text Key110741892
Report Number3004365956-2018-00186
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 05/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date08/08/2022
Device Catalogue Number031-33J
Device Lot Number74H1700251
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/25/2018
Initial Date Manufacturer Received 05/21/2018
Initial Date FDA Received06/12/2018
Supplement Dates Manufacturer Received07/20/2018
Supplement Dates FDA Received07/23/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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