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

Model Number 1182315

Device Problems Fluid/Blood Leak (1250); Dull, Blunt (2407); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

"the customer reported that the staff members stated that when the safety device is activated, it does not seal the end of the needle so blood is leaking out of the needle before they can remove the needle from the syringe.The staffs also reported that they are having more problems accessing the veins with these needles unless the vein is huge, resulting in multiple sticks to the patient.Additional information was received and stated that the needle didn't not seem to pierce the skin as easily as other products.Per staff members, the needles are flimsy and bend easily, making it more difficult to access the vein.The customer itself experienced this issue when she performed a hand stick last week.The customer further stated that activation of the shield is not a problem, the problem is after it is activated, the needles leak.The activation performs as expected.".

• Brand Name: MONOJECT HYPODERMIC SAFETY NEEDLE
• Type of Device: NEEDLE
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC; 311 s wacker dr, suite 4100; chicago IL 60604
• Manufacturer (Section G): SOL-MILLENNIUM MEDICAL INC; 311 s wacker dr, suite 4100; chicago IL
• Manufacturer Contact: jarryd franklin
• MDR Report Key: 18475973
• MDR Text Key: 333016082
• Report Number: 3014312726-2024-00041
• 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: 01/05/2024

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
• Device Model Number: 1182315
• Device Lot Number: 02102042
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1