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

Catalog Number 41894

Device Problem Failure to Deliver (2338)

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

Event Date 04/14/2015

Event Type  malfunction  

Event Description

The customer alleges that the nebulizer didn't produce any steam.No patient injury reported.

Manufacturer Narrative

Qn #(b)(4).A visual and dimensional inspection of the product involved in the complaint could not be conducted since the product or a picture of the defect was not provided.A functional inspection of the product involved in the complaint could not be conducted since the product was not returned.However, current production samples of catalog number 41893 nebulizer w/adult mask tbg, small volu batch number 74d1502890 were tested according to tp-0183 used to release the production parts and no issues were found than can lead to the condition reported by the customer.The fg 41893 uses the same nebulizer components that fg 41984 related to this customer complaint, (the only difference between them is the mask & the elastic).Device history records reviewed showed that there were no issues related to this issue neither on the product nor its components during the manufacture of the material.No corrective action can be established since the sample is not available to perform an investigation and determine the source of defect reported.Customer complaint cannot be confirmed due to lack of sample and no picture provided.If the device sample becomes available this investigation will be updated with the evaluation results.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that there was medicine residue inside the nebulization components.Functional testing was 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 device.

Event Description

The customer alleges that the nebulizer didn't produce any steam.No patient injury reported.

• Brand Name: HUDSON NEBULIZER W/PED MASK & TBG, SMALL VOLUM
• Type of Device: SMALLL VOLUME NEBULIZER
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; parque industrial finsa; nuevo laredo 8827 5; MX 88275
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 4759406
• MDR Text Key: 18027662
• Report Number: 3004365956-2015-00135
• 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: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/20/2015

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: Other
• Device Catalogue Number: 41894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/01/2015
• Initial Date FDA Received: 05/07/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/07/2015
• 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