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

Catalog Number 031-33J

Device Problem Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 09/04/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No visual, functional or dimensional inspection can be performed since the device sample was not returned for evaluation.The device history record review 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 similar complaints a capa file (b)(4) was opened to further investigate this issue.According to the capa investigation so far the root cause for the issue was the positioning of the thread lead and the softness of the new resin used for the snap adaptor.No conclusion can be established at this time based on the lack of device of sample.It is necessary to have physical sample in order to perform a proper investigation.If the device sample becomes available this complaint will be reopened.

Event Description

The customer alleges that the user was not able to connect the nebulizer adaptor with the flow meter.The screw-thread connector was stripped.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the internal threads of the adaptor were damaged.Functional testing could not be performed as the adaptor could not be connected correctly to the oxygen source due to the damage on the internal thread.Based on the visual exam, the reported complaint was confirmed.The root cause for the issue is the positioning of the thread lead and the softness of the new resin used for the snap adaptor.A capa was opened to address this issue.

Event Description

The customer alleges that the user was not able to connect the nebulizer adaptor with the flow meter.The screw-thread connector was stripped.

• 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: 5101770
• MDR Text Key: 26847309
• Report Number: 3004365956-2015-00295
• 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: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Followup
• Report Date: 09/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/11/2020
• Device Catalogue Number: 031-33J
• Device Lot Number: 74D1500992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2015
• 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