MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE

Catalog Number 031-33J

Device Problem Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2016

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 was not returned at the time of this report.There was not photo for review.A device history record review shows that the product was assembled and inspected according to our specifications.No conclusion can be established based on the information received at this time.It is necessary to have the physical sample involved in the complaint in order to perform a proper investigation.Customer complaint cannot be confirmed.If the device sample becomes available this investigation will be updated with the evaluation results.

Event Description

Customer complaint alleges "the user noticed that the connection part assembly to the flowmeter was unstably attached to the adaptor.Therefore, a new unit was used instead." no harm or injury to patient reported.Patient condition reported as "fine.".

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the sample was used as there were damages found on the internal thread and internal locks of the adaptor.No other issues were found.The damage found on the internal thread and locks of the adaptor are not acceptable according to the current specifications.Even with that condition, the sample was able to be tested on 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 were unstable; therefore it was not possible to perform such testing.In addition, the dual station lift test could not be performed.Attempts were made to duplicate the failure mode "flowmeter connection unstable" and there were two ways to duplicate them: the first one is by overtightening the nut adaptor onto the flow meter, and the second one was by manipulating the assembly connection.Other remarks: based on the investigation performed, the customer complaint of "unstable connection" 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 root cause for the condition reported could not be identified.Personnel from adaptor assembly line at the manufacturing facility were notified on feb-14-2017 for awareness.A conclusion code could not be found as the complaint was confirmed; however, a root cause could not be determined.

Event Description

Customer complaint alleges "the user noticed that the connection part assembly to the flowmeter was unstably attached to the adaptor.Therefore, a new unit was used instead." no harm or injury to patient reported.Patient condition reported as "fine.".

• Brand Name: HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE
• Type of Device: NEBULIZER ADAPTOR
• 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 Key: 6245260
• MDR Text Key: 64609843
• Report Number: 3004365956-2017-00044
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/19/2016

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: 05/16/2021
• Device Catalogue Number: 031-33J
• Device Lot Number: 74E1601942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2016
• Initial Date FDA Received: 01/12/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: FLOWMETER