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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEBULIZER ADAPTOR 028,STERILE,SHELFPAK,
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TELEFLEX MEDICAL HUDSON NEBULIZER ADAPTOR 028,STERILE,SHELFPAK, Back to Search Results
Catalog Number 031-28J
Device Problem Connection Problem (2900)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Date 04/25/2017
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 product was not received by the manufacturer at the time of this report.There was no photo for review.A device history record (dhr) review shows that the product was assembled and inspected according to our specifications.According to dhr, component (b)(4) was used during assembly.Regarding other customer complaints due to the same issue on component (b)(4), a capa file # (b)(4) was opened to perform a further investigation this issue (this capa is owned by r & d).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.Change order form for the design updated approved and dhf has been updated.All production from may 2016 forward is with the updated (b)(4) snap adaptor component.Capa (b)(4) is currently closed.Additionally, the personnel of the assembly line were notified on may-01-2017 for awareness.Customer complaint cannot be confirmed due the lack of the device sample to perform a proper investigation and determine the root cause.If the sample becomes available this investigation will be updated with the evaluation results.
 
Event Description
Customer complaint alleges "the adapter couldn't connect with the oxygen flow meter.As a result, a new kit was opened".Alleged defect reported as detected prior to use on a patient.There was no report of patient injury of consequence.No report of delay in treatment.
 
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.Functional testing was also performed and the device passed all testing except for the oxygen entrainment testing.The adaptor could not be connected correctly to the oxygen supply due to the damage on the adaptor.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 design change was initiated and all production from may 2016 forward is with the updated with the new snap adaptor component.
 
Event Description
Customer complaint alleges "the adapter couldn't connect with the oxygen flow meter.As a result, a new kit was opened".Alleged defect reported as detected prior to use on a patient.There was no report of patient injury of consequence.No report of delay in treatment.
 
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Brand Name
HUDSON NEBULIZER ADAPTOR 028,STERILE,SHELFPAK,
Type of Device
NEBULIZER
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 Key6550964
MDR Text Key74595856
Report Number3004365956-2017-00191
Device Sequence Number1
Product Code CAF
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K153010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial,Followup
Report Date 05/01/2017
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 Date06/03/2020
Device Catalogue Number031-28J
Device Lot Number74F1500449
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/30/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/01/2017
Initial Date FDA Received05/08/2017
Supplement Dates Manufacturer Received06/29/2017
Supplement Dates FDA Received06/30/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/02/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
OXYGEN FLOW METER
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