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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSNO NEBULIZER ADAPTOR 028,STERILE,SHELFPAK,; NEBULIZER (DIRECT PATIENT INTE
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TELEFLEX MEDICAL HUDSNO NEBULIZER ADAPTOR 028,STERILE,SHELFPAK,; NEBULIZER (DIRECT PATIENT INTE Back to Search Results
Catalog Number 031-28J
Device Problem Fitting Problem (2183)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/16/2018
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.Dhr shows that the product was assembled and inspected according to our specifications.Customer complaint cannot be confirmed due the lack of product sample to perform a proper investigation to confirm the alleged defect, and determine the root cause.Root cause is unknown.If the sample becomes available this report will be updated with the evaluation results.
 
Event Description
Customer complaint alleges "when connecting an adaptor to upper flowmeter, it was not fastened stably enough.Md switched to another one, with no problem." alleged issue reported as occurred during use.No report of patient injury or consequence.Patient condition reported as "fine".
 
Manufacturer Narrative
(b)(4).One (1) sample of subassembly ph12136 028 neb adaptor phantom holder was received for analysis.This subassembly is part of the fg 031-28j nebulizer adaptor 028, sterile, shelfpak, related to this customer complaint.The sample was tested on the dual station lift test and 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 oxygen entrainment testing with no functional issues.After the testing finished, the component nut adaptor was carefully disassembled from the component upper body and it was visually inspected.During the visual inspection it was found wear on its internal tabs.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 investigation performed, the complaint is confirmed.Although the complaint is confirmed, 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 nut adaptor is most likely caused by the end user during the connection of the adaptor into the flowmeter causing an unstable connection.However, the personnel of the assembly line were notified on jul-10-2018 for awareness.
 
Event Description
Customer complaint alleges "when connecting an adaptor to upper flowmeter, it was not fastened stably enough.Md switched to another one, with no problem." alleged issue reported as occurred during use.No report of patient injury or consequence.Patient condition reported as "fine".
 
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Brand Name
HUDSNO NEBULIZER ADAPTOR 028,STERILE,SHELFPAK,
Type of Device
NEBULIZER (DIRECT PATIENT INTE
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
MDR Report Key7541782
MDR Text Key109233847
Report Number3004365956-2018-00165
Device Sequence Number1
Product Code CAF
Combination Product (y/n)N
PMA/PMN Number
K153010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/17/2018
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 Date01/14/2022
Device Catalogue Number031-28J
Device Lot Number74A1701640
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/21/2018
Initial Date Manufacturer Received 05/17/2018
Initial Date FDA Received05/24/2018
Supplement Dates Manufacturer Received07/12/2018
Supplement Dates FDA Received07/13/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
FLOW METER; FLOW METER
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