MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ISO-NEB FILTERED NEBULIZER SYSTEM

Catalog Number 41755

Device Problem No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).It is unknown if the device sample is available for evaluation at the time of this report.A visual, functional, and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.The device history record could not be conducted since the lot number was not provided.No corrective action can be established at this moment since the product sample is not available for evaluation.Physical sample is necessary in order to confirm the failure mode.Customer complaint cannot be confirmed based only on the information provided, to perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved on this complaint.If the device sample becomes available at a later date this complaint will be updated.

Event Description

The customer alleges that there is no nebulization of the medication.

• Brand Name: HUDSON ISO-NEB FILTERED NEBULIZER SYSTEM
• 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: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 5945767
• MDR Text Key: 54540777
• Report Number: 3004365956-2016-00355
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/30/2016

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: Health Professional
• Device Catalogue Number: 41755
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/30/2016
• Initial Date FDA Received: 09/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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