MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ISO-NEB FILTERED NEBULIZER SYSTEM; NEBULIZER (DIRECT PATIENT INTE

Catalog Number 41755

Device Problem Failure to Deliver (2338)

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

Event Date 12/01/2017

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.The device history record (dhr) was reviewed, and no issues or discrepancies were found which could potentially be related to this complaint.The dhr shows that the device 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 to confirm the alleged defect and determine the source, it is necessary to evaluate the sample involved in this complaint.If the sample becomes available, this report will be updated with the evaluation results.

Event Description

Customer complaint alleges the device does not "spray".Alleged issue detected during use.There was no report of patient harm.

• Brand Name: HUDSON ISO-NEB FILTERED NEBULIZER SYSTEM
• 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: linda woodall ; 3015 carrington mill blvd; morrisville 27560 ; 9196942566
• MDR Report Key: 7147590
• MDR Text Key: 95846399
• Report Number: 3004365956-2017-00476
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K895231
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 12/19/2017

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 Expiration Date: 05/03/2022
• Device Catalogue Number: 41755
• Device Lot Number: 74E1700216
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2017
• Initial Date FDA Received: 12/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2017
• 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