MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE; NEBULIZER (DIRECT PATIENT INTE

Catalog Number 031-33J

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/28/2018

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.All materials used during the assembly met current specifications.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 the device does not properly attach to the flow meter.Alleged issuer reported as occurred during product prep.There was no report of patient injury or consequence.Patient condition reported as "fine".

Manufacturer Narrative

(b)(4).One (1) unit of subassembly ph12153 033 neb adaptor phantom holder was received for analysis.This subassembly is part of the fg 031-33j.During visual inspection , slight damage on the thread of component p/n tfx-001743 was observed , and component doesn't spin freely.Functional testing included dual station lift test, and general pull and push test with no functional issues found.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.Still the sample was able to be tested with no functional issues found.After the testing finished, the sample was carefully disassembled from the component upper body.Visual inspection found wear on its internal tabs.(cont.) other remarks: additional testing was performed.Two ways were found to duplicate the failure mode reported.One, by overtightening the nut adaptor into the flow meter.The second, by manipulating the assembly connection.Customer complaint is confirmed based on the additional testing of the sample received.However, 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 component tfx-001743 most likely be caused by the end user during the connection of the adaptor into the flowmeter that causes an unstable connection.However, the personnel of the assembly line were notified for awareness.Teleflex will continue to monitor customer feedback for complaints of this nature.

Event Description

Customer complaint alleges the device does not properly attach to the flow meter.Alleged issure reported as occurred during product prep.There was no report of patient injury or consequence.Patient condition reported as "fine".

• Brand Name: HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 7602069
• MDR Text Key: 111162443
• Report Number: 3004365956-2018-00180
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• PMA/PMN Number: K153010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/28/2018

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 Date: 08/17/2022
• Device Catalogue Number: 031-33J
• Device Lot Number: 74H1701585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Initial Date Manufacturer Received: 05/28/2018
• Initial Date FDA Received: 06/14/2018
• Supplement Dates Manufacturer Received: 07/20/2018
• Supplement Dates FDA Received: 07/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FLOW METER; FLOW METER