*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-07-15 for * manufactured by Medline Industries, Inc.

Event Text Entries

[4719235] Rn squeezed ampule for skin prep and a shard of glass pierced the side of the device and cut the nurse.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4091736
• MDR Report Key: 4091736
• Date Received: 2014-07-15
• Date of Report: 2014-07-15
• Date of Event: 2014-07-11
• Report Date: 2014-07-15
• Date Reported to FDA: 2014-07-15
• Date Reported to Mfgr: 2014-09-16
• Date Added to Maude: 2014-09-16
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: *
• Generic Name: IV STARTER KIT
• Product Code: LRS
• Date Received: 2014-07-15
• Model Number: *
• Catalog Number: *
• Lot Number: 14AB2062
• ID Number: *
• Operator: NURSE
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDLINE INDUSTRIES, INC
• Manufacturer Address: ONE MEDLINE PLACE MUNDELEIN IL 60060448 US 60060 4486

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-07-15