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 Problem No Consequences Or Impact To Patient (2199)

Event Date 02/02/2017

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 was not returned to the manufacturer at the time of this report.There was no picture of the defect provided.A device history record review shows that the product was assembled and inspected according to our specifications.Customer complaint cannot be confirmed due the lack of product sample to perform a proper investigation and determine the root cause.If the sample becomes available at a later date, this investigation will be updated with the evaluation results.

Event Description

Customer complaint alleges "air was leaking from the connection part between the adaptor and aquapak during use.Therefore, the adaptor was replaced by a new one." no harm to patient reported.Patient condition reported as "fine".

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and no defects were observed.The sample was assembled with a sterile water concha mini bottle in order to perform the oxygen entrainment test.During the testing, it was observed that one of the locks on the nut adaptor was bent.This is not acceptable according to current specifications.Although there was an issue with the nut adaptor, the sample was able to be functionally tested.During the testing no issues or discrepancies were found that can lead to the condition reported by the customer.Based on the investigation performed, the reported complaint could not be confirmed.The sample received was found to be within functional specifications.However, personnel of the assembly line were notified on mar-29-2017 for awareness.

Event Description

Customer complaint alleges "air was leaking from the connection part between the adaptor and aquapak during use.Therefore, the adaptor was replaced by a new one." no harm to patient reported.Patient condition 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: 6357462
• MDR Text Key: 68355468
• Report Number: 3004365956-2017-00070
• 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
• Type of Report: Initial,Followup
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/23/2021
• Device Catalogue Number: 031-33J
• Device Lot Number: 74H1602627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2016
• 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