MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC HENRY SCHEIN LUER LOCK SYRINGE

Model Number 900-7663

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

"as per the customer, the needle separated three or four different times into different patients' arms during administration of vaccine they are not sure of the patient specifics.The needle was removed from the patients' arms.None of the patients were harmed or required any medical attention.The needle was detaching itself from the luer lock, it was not holding.See attachment section for initial email and complaint report from customer.".

• Brand Name: HENRY SCHEIN LUER LOCK SYRINGE
• Type of Device: SYRINGE
• 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: 18476034
• MDR Text Key: 332446203
• Report Number: 3014312726-2024-00053
• Device Sequence Number: 1
• Product Code: FMF
• 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: 01/08/2024

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: 900-7663
• Device Lot Number: 01102050
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1