MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEBULIZER W/PED MASK & TBG, SMALL VOLUM

Catalog Number 41894

Device Problem No Flow (2991)

Patient Problem No Patient Involvement (2645)

Event Date 07/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device sample was returned to the manufacturer, but the results of the investigation are pending at the time of this report.

Event Description

The customer alleges that the nebulizer did not produce mist when pre-tested for patient use.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and no defects were observed.Functional testing was also performed and no issues were found.The sample was within specification.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned sample.

Event Description

The customer alleges that the nebulizer did not produce mist when pre-tested for patient use.

• Brand Name: HUDSON NEBULIZER W/PED MASK & TBG, SMALL VOLUM
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 5869106
• MDR Text Key: 51858476
• Report Number: 3004365956-2016-00298
• Device Sequence Number: 1
• Product Code: CAF
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 41894
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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