MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline; NEBULIZER,KIT,TMTHPIECE,6"RESER,7'TUB,UC

Model Number HCSU4483

Device Problems Disconnection (1171); Leak/Splash (1354); Connection Problem (2900)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/11/2023

Event Type  Injury  

Manufacturer Narrative

According to the facility after the nebulizer is setup at the bedside the "tubing pops off from the flowmeter or the bottom of the neb cup while also leaking".Per the facility "patients aren't receiving the full dose of medications and they've had to repeat breathing treatments".The sample is not available to be returned for evaluation.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

According to the facility after the nebulizer is setup at the bedside the "tubing pops off from the flowmeter or the bottom of the neb cup while also leaking".

• Brand Name: Medline
• Type of Device: NEBULIZER,KIT,TMTHPIECE,6"RESER,7'TUB,UC
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; 3 lakes dr; northfield, IL 60093
• MDR Report Key: 16195516
• MDR Text Key: 307604888
• Report Number: 1417592-2023-00025
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 10888277657625
• UDI-Public: 10888277657625
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HCSU4483
• Device Catalogue Number: HCSU4483
• Device Lot Number: 08522040027
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other