MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ADDIPAK FNS 5 ML; NEBULIZER (DIRECT PATIENT INTE

Model Number IPN049200

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Itching Sensation (1943)

Event Date 03/30/2021

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.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.

Event Description

It was reported "item caused itching and burning".Unknown if patient had previous allergies.No harm or injury reported.Patient condition reported as "fine".

• Brand Name: HUDSON ADDIPAK FNS 5 ML
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 900 west university dr.; arlington heights IL 60004
• Manufacturer Contact: marling heaton ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 11712725
• MDR Text Key: 252013268
• Report Number: 1417411-2021-00010
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 14026704628145
• UDI-Public: 14026704628145
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: IPN049200
• Device Catalogue Number: 200-59
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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