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

Model Number	IPN040620
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review could not be conducted since the lot number of the device was not provided.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
It was reported "water was found leaking from the collar of the adaptor while in use on a patient.Therefore, the adaptor was replaced with a new unit".No patient injury reported.Patient condition reported as "fine".
Event or Problem Description
It was reported "water was found leaking from the collar of the adaptor while in use on a patient.Therefore, the adaptor was replaced with a new unit".No patient injury reported.Patient condition reported as "fine".
Additional Manufacturer Narrative
(b)(4).One unit of 031-33j "nebulizer adaptor 033,sterile,japanese" was received for analysis.A visual exam was performed and damage was observed on the screw threads of the adaptor.No other issues were found.Functional testing could not be performed due to the damage on the adaptor.Based on the investigation performed, the complaint is confirmed.Although the complaint is confirmed, there is not sufficient evidence to assure that this issue was originated during the manufacturing process.It is possible that the damage on the adaptor could have been caused by the end user.A root cause for the issue could not be identified.

• Brand Name: HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE
• Common Device Name: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11231206
• Report Number: 3004365956-2021-00015
• Device Sequence Number: 3286008
• Product Code: CAF
• UDI-Device Identifier: 04026704581290
• UDI-Public: 04026704581290
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K153010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2021

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
• Operator of Device: No Information
• Device Model Number: IPN040620
• Device Catalogue Number: 031-33J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Initial Date Received by Manufacturer: 01/08/2021
• Supplement Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 03/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1