MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEBULIZER W/ADULT MASK & TBG, SMALL VOL; ADULT SMALL VOL. NEBULIZER

Catalog Number 41893

Device Problem Failure to Deliver (2338)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 11/27/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned for evaluation.A device history record review could not be conducted since the lot number was not provided.No corrective action can be established at this time since the device sample, picture or batch number are not available for evaluation.The device sample is necessary to conduct a proper investigation.Customer complaint cannot be confirmed due to the lack of device sample to perform a proper investigation and determine the root cause.If the device sample becomes available this compliant will be reopened.

Event Description

The customer alleges that the solution within the nebulizer chamber does not aerolize or steam.

• Brand Name: HUDSON NEBULIZER W/ADULT MASK & TBG, SMALL VOL
• Type of Device: ADULT SMALL VOL. 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: 5297550
• MDR Text Key: 33497891
• Report Number: 3004365956-2015-00387
• Device Sequence Number: 1
• Product Code: CCQ
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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: 12/01/2015

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: 41893
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/01/2015
• Initial Date FDA Received: 12/15/2015
• 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