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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEBULIZER W/ADULT MASK & TBG, SMALL VOL; ADULT SMALL VOLUME NEBULIZER
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TELEFLEX MEDICAL HUDSON NEBULIZER W/ADULT MASK & TBG, SMALL VOL; ADULT SMALL VOLUME NEBULIZER Back to Search Results
Catalog Number 41893
Device Problems Detachment Of Device Component (1104); Occlusion Within Device (1423); No Flow (2991)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Date 08/19/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).A visual inspection of the product involved in the complaint could not be conducted since the product or a picture of the device was not provided.A functional inspection of the product involved in the complaint could not be conducted since the product was not returned.However, current inventory samples of catalog number 41893 batch number 74j1500842 were tested according to (b)(4) used to release the production parts and no issues were found than can lead to the condition reported by the customer.The device history record was reviewed and there were no issues related to this complaint description neither on the product nor its components during the manufacture of the material.A corrective action cannot be applied since it is not possible to identify the defect reported and to investigate its root cause, in order to perform a proper investigation it is necessary to evaluate the sample involved in the incident.Customer complaint cannot be confirmed.Regarding this issue, the personnel from the assembly line and molding department were notified and made aware of this issue.
 
Event Description
The customer alleges that the oxygen inlet at the bottom of the micro mist nebulizer chamber was blocked and did not allow oxygen flow into the chamber.The oxygen tubing will then pop off with an increase in the flow rate.Another unit was obtained without issue.
 
Manufacturer Narrative
(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the nebulizer was occluded with plastic.Because of the occlusion, functional testing could not be performed.Based on the investigation performed, the reported complaint was confirmed.Corrective action has been taken at the manufacturing facility to avoid this issue in the future.In addition, manufacturing personnel have been made aware of this complaint.
 
Event Description
The customer alleges that the oxygen inlet at the bottom of the micro mist nebulizer chamber was blocked and did not allow oxygen flow into the chamber.The oxygen tubing will then pop off with an increase in the flow rate.Another unit was obtained without issue.
 
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Brand Name
HUDSON NEBULIZER W/ADULT MASK & TBG, SMALL VOL
Type of Device
ADULT SMALL VOLUME 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 Key5087192
MDR Text Key26162349
Report Number3004365956-2015-00286
Device Sequence Number1
Product Code CCQ
Combination Product (y/n)N
Reporter Country CodeSF
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Followup
Report Date 09/04/2015
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 Number41893
Device Lot Number74D1500535
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/05/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/18/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received11/10/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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