MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE; NEBULIZER (DIRECT PATIENT INTE

Catalog Number 031-33J

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/09/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device or a picture of the alleged defect was not provided.A device history record review shows that the device was assembled and inspected according to our specifications.No conclusion can be established at this time.It is necessary the physical sample in order to perform a proper investigation, to confirm the alleged defect and determine a root cause.Customer complaint cannot be confirmed based on the information received.If the device sample becomes available at a later date, this report will be updated with the evaluation results.

Event Description

Customer complaint from (b)(6) alleges "water leakage at around the connection part between the puncture pin of return tube and the aquapak was found during use".Alleged defect reported as detected during use.No report of patient harm.Patient condition reported as "fine".

Manufacturer Narrative

Qn# (b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that there was a loose connection on the nebulizer assembly.It was also noticed that there was adhesive residue on the tubing.Pull testing and oxygen entrainment testing could not be performed due to the loose connection.However dual station lift testing was able to be performed and met current specifications.Based on the investigation performed, the reported complaint was confirmed.A non-conformance was opened to address this issue.A conclusion code could not be found as the complaint was confirmed; however, a root cause was not established.

Event Description

Customer complaint from (b)(6) alleges "water leakage at around the connection part between the puncture pin of return tube and the aquapak was found during use".Alleged defect reported as detected during use.No report of patient harm.Patient condition reported as "fine".

• Brand Name: HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• 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: 6827886
• MDR Text Key: 83895029
• Report Number: 3004365956-2017-00333
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K153010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/17/2017

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: No Information
• Device Expiration Date: 11/03/2021
• Device Catalogue Number: 031-33J
• Device Lot Number: 74L1600507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2017
• Initial Date FDA Received: 08/29/2017
• Supplement Dates Manufacturer Received: 10/02/2017
• Supplement Dates FDA Received: 10/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1