MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC; IV STARTER KIT

Lot Number 14AB2062

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Laceration(s) (1946)

Event Date 07/11/2014

Event Type  malfunction  

Event Description

Rn squeezed ampule for skin prep and a shard of glass pierced the side of the device and cut the nurse.

• Type of Device: IV STARTER KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC; one medline place; mundelein IL 60060 448
• MDR Report Key: 4091736
• MDR Text Key: 4719235
• Report Number: 4091736
• Device Sequence Number: 1
• Product Code: LRS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Lot Number: 14AB2062
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/15/2014
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2014
• Patient Sequence Number: 1