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

Model Number 41893

Device Problems Failure to Deliver (2338); No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2014

Event Type  malfunction  

Event Description

The customer alleges that the device failed to nebulize the fluid in the chamber.No pt injury.

Manufacturer Narrative

(b)(4).The device history record (dhr) review could not be conducted since the lot number was not provided.Correction action cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the defect.Customer complaint cannot be confirmed based only on the info provided.An attempt to duplicate the failure mode was made but at the time there is no inventory of the involved product code available at the facility nor is it being manufactured at the time.If the device sample becomes available this investigation will be updated with the eval results.

• Brand Name: HUDSON NEBULIZER W/ADULT MASK AND TBG, SMALL VOL
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; ave. industrias no.5954; parque industrial finsa; nuevo laredo, tamaulipas ; MX
• Manufacturer Contact: margie burton, rn, ra ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 4412032
• MDR Text Key: 5164329
• Report Number: 3004365956-2015-00007
• Device Sequence Number: 1
• Product Code: CCQ
• Combination Product (y/n): N
• Reporter Country Code: ZA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/15/2014

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 Model Number: 41893
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/15/2014
• Initial Date FDA Received: 01/08/2015
• 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