MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - NORTHFIELD IV GRAVITY SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number DYNDTN1512

Device Problem Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 04/26/2023

Event Type  malfunction  

Event Description

Iv gravity set tubing kinked and closed under drip chamber x4 sets.Reference report: mw5117183, mw5117185, mw5117186.

• Brand Name: IV GRAVITY SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - NORTHFIELD
• MDR Report Key: 16853638
• MDR Text Key: 314499220
• Report Number: MW5117184
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DYNDTN1512
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1