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

Catalog Number 031-33J

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2017

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 at the time of this report.A device history record investigation shows that the device was assembled and inspected according to our specifications.Customer complaint cannot be confirmed based on the information received.It is necessary to have the device sample involved in the complaint to perform a proper and thorough investigation to determine the root cause.If the device becomes available at a later date, this investigation will be updated with the evaluation results.Personnel of the assembly line were notified for awareness.

Event Description

Customer complaint alleges "2 hours after starting the therapy, it was report that the connection between the adaptor and oxygen flowmeter was unstable, and detached from the adaptor".Customer reports there was no health injury to the patient.Patient condition reported as "fine".

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and no issues were found.Functional testing was also performed and the sample passed the tests.During the setup of the oxygen entrainment testing, however, it was observed that the assembly of the nut adaptor and the upper body component was unstable.Even with that condition, the sample was able to be tested with no functional issues.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found and the sample functioned as intended.

Event Description

Customer complaint alleges "2 hours after starting the therapy,it was report that the connection between the adaptor and oxygen flowmeter was unstable, and detached from the adaptor".Customer reports there was no health injury to the patient.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: 6936918
• MDR Text Key: 90051564
• Report Number: 3004365956-2017-00363
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/10/2021
• Device Catalogue Number: 031-33J
• Device Lot Number: 74L1601445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2016
• 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