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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 Connection Problem (2900)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/07/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been received by the manufacturer for evaluation at the time of this report.A device history record review could not be conducted since the lot number was not provided.Customer complaint cannot be confirmed at this time.It is necessary to have the physical sample in order to perform a proper investigation.If the sample becomes available this report will be updated with the evaluation results.
 
Event Description
Customer complaint alleges: "it was reported that the user was not able to connect the adaptor to the flowmeter because the connecting part assembly was so unstable.Having been tried to connect several times, the screw thread was stripped.(cont.) therefore, a new unit in the hospital stock was opened instead.".
 
Manufacturer Narrative
(b)(4).(b)(4) unit of subassembly ph12153 033 neb adaptor phantom holder was received for analysis.This subassembly is part of the 031-33j nebulizer adaptor 033, sterile, japanese related to this customer complaint.It was observed that the sample has the older design of the snap-on flowmeter adaptor and damage was found on the internal thread of the adaptor.The sample was tested on the dual station lift test and general pull and push test procedures with no functional issues.The damage on the internal thread of the adaptor is not acceptable according to current specifications.Even with that condition, the sample was able to be tested on the oxygen entrainment test.However, during the setup of such testing it was observed that the assembly of the nut adaptor and the upper body component was unstable and the testing failed due to such condition.After the testing was finished, the adaptor was carefully disassembled from the upper body and it was visually inspected.During the visual inspection wear was found on the internal tabs.Based on the investigation performed, the reported complaint was confirmed.Damage was found on the internal thread of the adaptor.Regarding other customer complaints due to the same issue on the adaptor, a capa was opened to further investigate.According to the capa investigation, the root cause for the issue was the positioning of the thread lead and the softness of the new resin used for the snap adaptor.All production from may 2016 forward is with the updated snap adaptor component.The capa is currently closed.Additionally, personnel of the assembly line were notified on oct-16-2018 for awareness.
 
Event Description
Customer complaint alleges: "it was reported that the user was not able to connect the adaptor to the flowmeter because the connecting part assembly was so unstable.Having been tried to connect several times, the screw thread was stripped.(cont.) therefore, a new unit in the hospital stock was opened instead.".
 
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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 Key7906655
MDR Text Key121714273
Report Number3004365956-2018-00274
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 09/07/2018
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 Catalogue Number031-33J
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/02/2018
Initial Date Manufacturer Received 09/07/2018
Initial Date FDA Received09/25/2018
Supplement Dates Manufacturer Received10/18/2018
Supplement Dates FDA Received10/24/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
FLOWMETER; FLOWMETER
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