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

Catalog Number 031-33J

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2015

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 provided.No photo available.The device history record shows that the product was assembled and inspected according to our specifications.No conclusion can be established at this time based on the lack of device sample.It is necessary to evaluate the device sample in order to perform a proper investigation.If the device sample becomes available this complaint will be reopened.The customer complaint cannot be confirmed due to the lack of the device sample.The personnel from the assembly line were notified in order to keep them aware of this issue.

Event Description

The customer alleges an air leak during use.A new adaptor was used.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and a loose connection was observed on the nebulizer assembly.It was also found that there was damage on the internal locks of the adaptor.Functional testing could not be performed due to the damage on the adaptor.It could not be connected to the oxygen supply.Based on the investigation performed, the reported complaint was confirmed.The root cause for the issue was found to be 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.In addition , personnel on the assembly line were notified on feb-01-2016.

Event Description

The customer alleges an air leak during use.A new adaptor was used.The patient's condition is reported as fine.

• Brand Name: HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE
• 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: 5270575
• MDR Text Key: 32775790
• Report Number: 3004365956-2015-00384
• 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: Initial,Followup
• Report Date: 11/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/27/2020
• Device Catalogue Number: 031-33J
• Device Lot Number: 74C1503091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2016
• 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