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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE
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TELEFLEX MEDICAL HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE Back to Search Results
Catalog Number 031-33J
Device Problems Loose or Intermittent Connection (1371); Connection Problem (2900)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 07/10/2017
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.A device history record investigation shows that the device was assembled and inspected according to our specifications.Customer complaint cannot be confirmed based on the information received.In order to perform a proper investigation to confirm the alleged defect reported and determine any corrective actions, it is necessary to have the device sample.If the device sample becomes available at a later date, this report will be updated with the evaluation results.
 
Event Description
Customer complaint from (b)(6) alleges "the adaptor was difficult to fit the oxygen flow meter due to connection loose." it was reported the adaptor was replaced with a new one.Alleged defect was reported as detected prior to patient use.No report of patient harm or delay in treatment.
 
Manufacturer Narrative
(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the puncture pin protector was missing.No other issues were found.The sample was tested on the dual station lift test and the general pull and push test procedures with no functional issues.However, during the setup of the oxygen entrainment test it was observed that the assembly of the nut adaptor component and the upper body component was unstable.Even with that condition, the sample was able to be tested on the oxygen entrainment testing but failed the testing due to this condition.After the oxygen entrainment testing failed, the component was carefully disassembled from the component upper body and it was visually inspected.During the visual inspection it was found wear on its internal locks.Attempts to duplicate the failure mode were performed and there are two ways to duplicate them: the first one is by overtightening the nut adaptor into the flow meter.The second one is by manipulating the assembly connection.Based on the functional inspection results of the sample received, the complaint is 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 thread of the adaptor is most likely caused by the end user during the connection of the adaptor into the flowmeter that causes an unstable connection.However, personnel from the adaptor assembly line were notified on oct-11-2017 for awareness.
 
Event Description
Customer complaint from (b)(6) alleges "the adaptor was difficult to fit the oxygen flow meter due to connection loose." it was reported the adaptor was replaced with a new one.Alleged defect was reported as detected prior to patient use.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
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 Key6732653
MDR Text Key80703747
Report Number3004365956-2017-00299
Device Sequence Number1
Product Code CAF
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date10/21/2021
Device Catalogue Number031-33J
Device Lot Number74K1602201
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/30/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/12/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/18/2016
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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