MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE; I.V. START KIT

Model Number DYNDV1779

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 08/10/2021

Event Type  malfunction  

Event Description

Rn filled a workers' comp claim due to harp, stabbing, radiating pain when activating the 1cc chloroprep for iv starts.

• Brand Name: MEDLINE
• Type of Device: I.V. START KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline pl.; mundelein IL 60060
• MDR Report Key: 12445997
• MDR Text Key: 270507717
• Report Number: 12445997
• Device Sequence Number: 1
• Product Code: LRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/20/2021

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
• Device Operator: Health Professional
• Device Model Number: DYNDV1779
• Device Catalogue Number: DYNDV1779
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/20/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/09/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1