MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON MICRO MIST NEBULIZER W/ELONG; NEBULIZER (DIRECT PATIENT INTE

Catalog Number 1886

Device Problem Failure to Deliver (2338)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/05/2017

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.However, material from the production line was verified and no issues were found that can lead this customer complaint.A device history record review shows that the product was assembled and inspected according to our specifications.Customer complaint cannot be confirmed based only on the information provided.In order to perform a proper and thorough investigation to confirm the alleged defect reported and determine the root cause, it is necessary to evaluate the sample involved in this complaint.If the device becomes available at a later date, this report will be updated with the evaluation results.

Event Description

Customer complaint alleges that "micronebulizer does not make the appropriate cloud for patient treatment." alleged malfunction reported as detected prior to patient use during functional testing.There was no report of patient harm.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the top stem of the jar is completely broken.What the customer is reporting as "not misting properly" is actually a damage issue on the nebulizer jar.Based on the visual exam, the reported complaint is confirmed.Although the complaint is confirmed, a root cause for the issue could not be identified.There is not sufficient evidence to assure this issue was originated during the manufacturing process.*a conclusion code could not be found as the complaint was confirmed; however, a root cause was not established.

Event Description

Customer complaint alleges that "micronebulizer does not make the appropriate cloud for patient treatment." alleged malfunction reported as detected prior to patient use during functional testing.There was no report of patient harm.

• Brand Name: HUDSON MICRO MIST NEBULIZER W/ELONG
• 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: 7099945
• MDR Text Key: 94273665
• Report Number: 3004365956-2017-00420
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K930525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/02/2020
• Device Catalogue Number: 1886
• Device Lot Number: 74J1500049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• 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