MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-CARE SAFETY NEEDLE

Device Problem Material Twisted/Bent (2981)

Patient Problem Needle Stick/Puncture (2462)

Event Type  Injury  

Event Description

"customer reported: sol care needle - bent sticking through plastic cap.Photo provided.See attachment section for initial email and complaint report from customer.".

• Brand Name: SOL-CARE SAFETY NEEDLE
• Type of Device: NEEDLE
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC; 311 s wacker dr, suite 4100; chicago IL
• Manufacturer (Section G): SOL-MILLENNIUM MEDICAL INC; 311 s wacker dr, suite 4100; chicago IL
• Manufacturer Contact: jarryd franklin
• MDR Report Key: 18475974
• MDR Text Key: 332445697
• Report Number: 3014312726-2024-00035
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1