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

Model Number P180001PP

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

During medication preparation, writer secured needle to the syringe.Writer punctured the vial and got the appropriate dose successfully.No problems noted at this time.Upon finishing administrating the medication in client's deltoid, the needle detached from the syringe and stayed in clients deltoid as writer pulled the whole device out.Needle was disposed of safely into sharps container.A full dose was given before the needle detached from the syringe.Writer removed the needle from client's deltoid and let the family and ahn aware about the event.

• Brand Name: SOL-M 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: 18476040
• MDR Text Key: 332446241
• Report Number: 3014312726-2024-00038
• 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: 01/04/2024

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
• Device Model Number: P180001PP
• Device Lot Number: 08103002
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1