MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-M TUBE HOLDER WITH LUER LOCK ADAPTER; BLOOD COLLECTION

Model Number 110201050003

Device Problem Fracture (1260)

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

Event Type  malfunction  

Event Description

Customer reported the blue portion of the needless transfer device broke off on the cap of the arterial line.

• Brand Name: SOL-M TUBE HOLDER WITH LUER LOCK ADAPTER
• Type of Device: BLOOD COLLECTION
• 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: 18580397
• MDR Text Key: 334781198
• Report Number: 3014312726-2024-00180
• Device Sequence Number: 1
• Product Code: JKA
• 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: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 110201050003
• Device Lot Number: 05206013
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• Patient Sequence Number: 1