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 11/30/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual , dimensional and functional inspection of the device involved in this complaint could not be conducted since the device was not returned at the time of this report.There was no photo for review.A device history record review shows that the product was assembled and inspected according to our specifications.Customer complaint cannot be confirmed at this time, due the lack of device sample to perform a proper investigation and determine the root cause.If the sample becomes available this investigation will be updated with the evaluation results.

Event Description

Customer complaint alleges " the connection part assembly to the flowmeter was unstably attached to the adaptor.Therefore, a new unit was used instead.".

Manufacturer Narrative

Qn#(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the sample had signs of use as damages were found on the internal locks of the adaptor.No other issues were found.The damage found on the internal locks of the adaptor is not acceptable according to current specifications.Functional testing was performed and no issues were found.However, during the setup of the oxygen entrainment testing, it was observed that the assembly of the nut adaptor component and the upper body component was unstable as the upper body was disconnected from the nut adaptor; therefore it was not possible to perform such testing.Attempts to duplicate the failure mode "flowmeter connection unstable" were performed and there are two ways to duplicate them: the first one is by overtightening the nut adaptor onto the flow meter.The second one is by manipulating the assembly connection until components get disconnected.Based on the investigation performed, the reported complaint was confirmed.Although the condition reported is observed on the sample provided, there is not sufficient evidence to assure that this issue was originated during the manufacturing assembly or molding process (damaged internal locks).Other remarks: the root cause for the condition reported could not be identified.However, personnel from adaptor assembly line at the manufacturing facility were notified on jan-17-2017 for awareness.A conclusion code could not be found as the complaint was confirmed; however, a root cause was not established.

Event Description

Customer complaint alleges "the connection part assembly to the flowmeter was unstably attached to the adaptor.Therefore, a new unit was used instead.".

• 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 Key: 6199538
• MDR Text Key: 63197734
• Report Number: 3004365956-2016-00462
• 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: 12/01/2016

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: 04/21/2021
• Device Catalogue Number: 031-33J
• Device Lot Number: 74D1601769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2016
• Initial Date FDA Received: 12/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2016
• 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