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

Catalog Number 41893

Device Problem Failure to Deliver (2338)

Patient Problem No Patient Involvement (2645)

Event Date 06/13/2016

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.The device history record of batch number 74a1603228 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No non conformance reports were originated for the lot in question that can be associated to the complaint reported.Dhr shows that the product was assembled & inspected according to our specifications.Customer complaint cannot be confirmed due the lack of sample.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 and it is not being manufactured at the time.If the device sample becomes available this investigation will be updated with the evaluation results.

Event Description

The customer alleges that there is not mist coming out of the device.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that there was residue inside the jar, jet, cap and mask.Functional testing was performed on the returned sample and there were no issues found.A mist was produced from the chamber of the nebulizer.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 there is not mist coming out of the device.

• Brand Name: HUDSON NEBULIZER W/ADULT MASK & TBG, SMALL VOL
• 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: 5761530
• MDR Text Key: 48542276
• Report Number: 3004365956-2016-00260
• 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: 06/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/29/2021
• Device Catalogue Number: 41893
• Device Lot Number: 74A1603228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2016
• 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