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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEBULIZER ADAPTOR 028,SHELFPAK
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TELEFLEX MEDICAL HUDSON NEBULIZER ADAPTOR 028,SHELFPAK Back to Search Results
Catalog Number 031-28
Device Problems Connection Problem (2900); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/07/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).A dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.No photo for review.A visual and functional inspection of the product involved in the complaint could not be conducted since the product was not returned.However, as an additional test, oxygen entrainment testing oxygen entrainment testing was performed to 42 subassembly (p/n: ph12136 028 neb adaptor phantom holder) production samples that were taken randomly from adaptors assembly line.These components are part of catalog number ip-5035 neb adaptor 028, non-sterile batch 74j1601650.Catalog number ip-5035 uses the same subassembly 12136 than catalog number 031-28 related to this customer complaint.During the testing and visual inspection no issues or discrepancies were found than can lead to the condition reported by the customer.A device history record review could not be conducted since the lot number was not provided.No conclusion can be established at this time.Customer complaint cannot be confirmed.If the device sample becomes available this investigation will be updated with the evaluation results.The personnel of the assembly line will be notified for awareness.
 
Event Description
The customer alleges that the rt is having difficulty getting the wingnut to start easily without cross threading the device.The adaptor was changed out.The patient did not suffer any trauma as a result of the interruption in treatment and bagging.
 
Manufacturer Narrative
(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that there was damage on the internal thread of the adaptor.The damage on the internal thread of the adaptor is not acceptable according to current specifications.Functional testing was performed and two of the tests were passed, however, oxygen entrainment testing could not be performed due to the damage on the threads.Based on the investigation performed, the reported complaint was confirmed.The root cause for the issue was found to be the positioning of the thread lead and the softness of the new resin used for the snap adaptor.A capa was opened to address this issue.
 
Event Description
The customer alleges that the rt is having difficulty getting the wingnut to start easily without cross threading the device.The adaptor was changed out.The patient did not suffer any trauma as a result of the interruption in treatment and bagging.
 
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Brand Name
HUDSON NEBULIZER ADAPTOR 028,SHELFPAK
Type of Device
NEBULIZER ADAPTOR
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
parque industrial finsa
nuevo laredo 88275
MX   88275
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key5959474
MDR Text Key55012413
Report Number3004365956-2016-00359
Device Sequence Number1
Product Code CAF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other
Remedial Action Other
Type of Report Initial,Followup
Report Date 09/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number031-28
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/03/2016
Is the Reporter a Health Professional? No
Date Manufacturer Received10/25/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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