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

Catalog Number 031-33J

Device Problems Leak/Splash (1354); Connection Problem (2900)

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

Event Date 07/10/2015

Event Type  malfunction  

Event Description

The customer alleges that air is leaking because the adaptor didn't fit with the oxygen flowmeter.

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.The device history record was reviewed and 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 time since the device sample or picture is not available for evaluation.Customer complaint cannot be confirmed due to the lack of the device sample needed 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 it was observed that the threads inside the adaptor were partially stripped, or cross-threaded.Functional testing was performed and no leaking was found.Although no leaking was detected, visual inspection found that the threads of the nut were stripped, which could lead to a leak.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.Teleflex has opened a capa to further investigate this issue.

Event Description

The customer alleges that air is leaking because the adaptor didn't fit with the oxygen flowmeter.

• 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: 4946622
• MDR Text Key: 6190417
• Report Number: 3004365956-2015-00200
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/28/2020
• Device Catalogue Number: 031-33J
• Device Lot Number: 74C1503092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2015
• 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