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

Catalog Number 41894

Device Problem No Flow (2991)

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

Event Date 10/09/2015

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.Current inventory samples of catalog #41894 nebulizer w/ped mask & tbg, small volume batch# 74k1501246 were tested and no issues were found that can lead to the condition reported by the customer.The device history record was reviewed and no issues or discrepancies were found which could potentially be related to this complaint.Dhr shows that the product was assembled & inspected according to our specifications.A corrective action cannot be applied since it is not possible to identify the defect reported and to investigate its root cause, in order to perform a proper investigation it is necessary to evaluate the sample involved on the incident.Customer complaint cannot be confirmed due to the lack of device sample.If the sample becomes available this investigation will be updated with the evaluation results.

Event Description

The customer alleges that there was no steam was produced from the nebulizer when the device was tested before treatment to a patient.

Manufacturer Narrative

(b)(4) event date:.-corrected to (b)(6) 2015.Date of this report: corrected to 10/15/2015.The sample was returned for evaluation.A visual exam was performed and there were no issues observed.Functional testing was also performed and the sample was found to be 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 there was no steam was produced from the nebulizer when the device was tested before treatment to a patient.

• 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: 5174073
• MDR Text Key: 29191019
• Report Number: 3004365956-2015-00325
• 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
• Type of Report: Initial,Followup
• Report Date: 10/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 41894
• Device Lot Number: 74F1500897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2015
• 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