MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON MICRO MIST NEBULIZER W/TEE,TBG & MTHPC; NEBULIZER (DIRECT PATIENT INTE

Catalog Number 1883

Device Problem Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2017

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 was not returned to the manufacturer at the time of this report.In order to perform a proper and thorough investigation to confirm the alleged defect reported, and determine the source, it is necessary to evaluate the sample involved on this complaint.However, material from the production line was verified and no issues were found that can lead this customer complaint.A device history record review found that regarding this same issue a non-conformance (nc) has been generated.This customer complaint cannot be confirmed based only on the information provided.However, regarding this same issue there is a non-conformance to further investigate this issue and document corrective actions.If the device sample becomes available at a later date this report will be updated accordingly.

Event Description

Customer complaint alleges "the product is not nebulizing." alleged malfunction reported as detected during use.It was reported there was no injury.There was no report of necessary medical intervention.

• Brand Name: HUDSON MICRO MIST NEBULIZER W/TEE,TBG & MTHPC
• 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: 7067981
• MDR Text Key: 93602972
• Report Number: 3004365956-2017-00416
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K930525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/14/2017

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: 1883
• Device Lot Number: 74F1702861
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/14/2017
• Initial Date FDA Received: 11/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2017
• 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