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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 Known Impact Or Consequence To Patient (2692)
Event Date 12/22/2017
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 device, or a picture of the alleged defect, was not provided at the time of this report.The device history record (dhr) has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.The dhr shows that the product was assembled and inspected according to our specifications.Customer complaint cannot be confirmed.No corrective actions can be assigned at this time.It is necessary to have the device sample in order to perform a proper and thorough investigation to confirm the alleged defect, determine a root cause, and establish corrective actions.If the device sample becomes available this report will be updated accordingly.
 
Event Description
Customer complaint alleges "the adaptor was unable to be attached to the oxygen flow meter straight, then the connecting part became unsteady and the adapter got detached from the flow meter.As a result, it was replaced by a new kit.This event occurred before use on a patient." there was no report of patient harm or delay in treatment.
 
Manufacturer Narrative
Qn#: (b)(4).The sample was returned for evaluation.A visual exam was performed and no issues were found.Functional testing was also performed and the sample passed the tests.During the setup of the oxygen entrainment testing, however, it was observed that the assembly of the nut adaptor and the upper body component was unstable.Even with that condition, the sample was able to be tested with no functional issues.As an additional test and even with the unstable connection on the assembly, the sample was assembled with a sterile water concha mini bottle.However, during the setup of the oxygen entrainment test it was observed that the nut adaptor disconnected from the upper body.Therefore, it was not possible to perform such testing.The adaptor was visually inspected and it was found that there was wear on the internal tabs.Attempts to duplicate the failure mode were performed and there are two ways to duplicate th em: the first one is by overtightening the nut adaptor into the flow meter.The second one is by manipulating the assembly connection.(con't) other remarks: based on the investigation performed, the reported complaint was confirmed.Although the condition observed on the sample provided, there is not sufficient evidence to assure that this issue was originated during the manufacturing assembly or molding process.The wear on the internal tabs of the adaptor most likely was caused by the end user during the connection of the adaptor into the flowmeter.However, the personnel of the assembly line were notified on feb-08-2018 for awareness.
 
Event Description
Customer complaint alleges "the adaptor was unable to be attached to the oxygen flow meter straight, then the connecting part became unsteady and the adapter got detached from the flow meter.As a result, it was replaced by a new kit.This event occurred before use on a patient." there was no report of patient harm or delay in treatment.
 
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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
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 Key7183437
MDR Text Key97011243
Report Number3004365956-2018-00025
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/25/2017
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 Date04/11/2022
Device Catalogue Number031-33J
Device Lot Number74D1701005
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/26/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/25/2017
Initial Date FDA Received01/11/2018
Supplement Dates Manufacturer Received02/12/2018
Supplement Dates FDA Received02/13/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/10/2017
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
FLOWMETER
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