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

Catalog Number 031-33J

Device Problem Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 03/05/2018

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) of the device 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.It is necessary to receive the physical sample in order to perform a proper and thorough investigation.No conclusion can be established at this time.Customer complaint cannot be confirmed.If the sample becomes available this report will be updated with the evaluation results.However, the personnel of the assembly line were notified for awareness.

Event Description

Customer complaint alleges "that the connecting part of flow meter and adaptor was unstable, then it was replaced by a new kit.The new one was used without any issue".

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.The sample was returned for evaluation.A visual exam was performed and it was observed that the nut adaptor did not spin freely.Functional testing was also performed and the sample passed the tests.During the setup of the oxygen entrainment testing, however, it was observed that the assembly of the nut adaptor and the upper body component was unstable.Even with that condition, the sample was able to be tested with no functional issues.After the testing was finished, the adaptor was carefully disassembled from the upper body and it was visually inspected.During the visual inspection it was found there was wear on the 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.(con't) other remarks: based on the investigation performed, the reported complaint was 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 tabs of the adaptor most likely was caused by the end user during the connection of the adaptor into the flowmeter.However, the personnel of the assembly line were notified on apr-11-2018 for awareness.

Event Description

Customer complaint alleges "that the connecting part of flow meter and adaptor was unstable, then it was replaced by a new kit.The new one was used without any issue".

• Brand Name: HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• 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: 7361331
• MDR Text Key: 103298935
• Report Number: 3004365956-2018-00084
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K153010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/24/2022
• Device Catalogue Number: 031-33J
• Device Lot Number: 74G1702387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2017
• 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