MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. IV START KIT; GENERAL/PLASTIC SURGICAL PROCEDURE KIT, NON-MEDICATED, SINGLE-USE

Catalog Number DYND74284

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Skin Tears (2516)

Event Date 09/25/2019

Event Type  Injury  

Event Description

Dressing type from the iv start kit would not release from patient skin causing skin tear.

• Brand Name: IV START KIT
• Type of Device: GENERAL/PLASTIC SURGICAL PROCEDURE KIT, NON-MEDICATED, SINGLE-USE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 9864984
• MDR Text Key: 184468014
• Report Number: 9864984
• 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: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: DYND74284
• Device Lot Number: 19SBC751
• 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: 02/04/2020
• Event Location: Other
• Date Report to Manufacturer: 03/23/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24820 DA