MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number 80215

Device Problems Fluid/Blood Leak (1250); Device Contamination with Body Fluid (2317); Malposition of Device (2616)

Patient Problem Blood Loss (2597)

Event Date 02/17/2015

Event Type  malfunction  

• Brand Name: JELCO
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene, NH 03431
• MDR Report Key: 4598180
• Report Number: 4598180
• Device Sequence Number: 1
• Product Code: FMI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 02/19/2015

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: Other
• Device Model Number: 80215
• Device Catalogue Number: 80215
• Device Lot Number: 14J26 (POSSIBLE LOT)
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/19/2015
• Event Location: Hospital
• Date Report to Manufacturer: 03/13/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/19/2015
• Patient Sequence Number: 1