MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE

Catalog Number 031-33J

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/10/2015

Event Type  malfunction  

Event Description

The customer alleges that the adaptor couldn't generate a fine mist.A new adaptor was used.The patient's condition is reported as fine.

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 received at our facility.Records reviewed showed that there were no issues related to functional issues neither on the product nor its components during the manufacture of the material.No corrective action can be established at this moment since the device sample or a picture is not available for evaluation.Customer complaint cannot be confirmed due to the lack of product sample to perform a proper investigation and determine the root cause.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 compliant will be reopened.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and there were no defects observed.During the first functional test, a very light mist was produced.A second functional test was then performed and the nebulizer misted at 8 lpm and 10 lpm.Based on the investigation performed, the reported complaint could not be confirmed.The dhrs reviewed showed that there were no issues related to functional issues neither on the product nor its components during the manufacture of the material.Based on the results of the investigation and the available information, no root cause could be determined.

Event Description

The customer alleges that the adaptor couldn't generate a fine mist.A new adaptor was used.The patient's condition is reported as fine.

• Brand Name: HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE
• Type of Device: ADAPTOR
• 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: 4946568
• MDR Text Key: 21058415
• Report Number: 3004365956-2015-00201
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,company represent
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/13/2015

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 Expiration Date: 04/30/2019
• Device Catalogue Number: 031-33J
• Device Lot Number: 74D1400276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/13/2015
• Initial Date FDA Received: 07/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2014
• 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