MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON UP-DRAFT II OPTI-NEB NEBULIZER W/PED

Catalog Number 1707

Device Problem No Flow (2991)

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

Event Date 12/28/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).It was reported that the customer discarded the device involved in this report.A visual, dimensional, and functional inspection of the device involved in this complaint could not be conducted since the device was not returned.There was no picture provided to review.A device history record investigation 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 investigation and determine the source of alleged defect reported, it is necessary to evaluate the device sample involved on this complaint.If the device sample becomes available at a later date, this report will be updated with the evaluation results.

Event Description

Customer complaint alleges the device was reported to have had no flow when tested prior to patient use.There was no report of patient harm or delay in treatment.

• Brand Name: HUDSON UP-DRAFT II OPTI-NEB NEBULIZER W/PED
• 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: linda woodall ; 3015 carrington mill blvd; morrisville 27560 ; 9196942566
• MDR Report Key: 6290828
• MDR Text Key: 66215239
• Report Number: 3004365956-2017-00060
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/17/2017

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 Catalogue Number: 1707
• Device Lot Number: 74H1602352
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/17/2017
• Initial Date FDA Received: 01/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2016
• 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