MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-CARE SAFETY BLOOD COLLECTION NEEDLE; SAFETY BUTTERFLY NEEDLE & SET

Device Problem Loose or Intermittent Connection (1371)

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

Event Type  malfunction  

Event Description

Distributor reported the following: these were used on patients during an evaluation.The clinician drew the patients' blood and collected the sample.The clinician then put the collection set down on a tray to attend to the patient.Once the collection set was placed on the tray-the lure slip came apart-resulting in blood exposure in the lab collection area.This resulted in blood splatter on the walls.This patient was hiv positive which created additional concern.No one was injured as a result of this incident.Per report medical intervention was not required.Samples are not available.See attachment section for initial email and complaint report from customer.

• Brand Name: SOL-CARE SAFETY BLOOD COLLECTION NEEDLE
• Type of Device: SAFETY BUTTERFLY NEEDLE & SET
• 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: 18425479
• MDR Text Key: 331906324
• Report Number: 3014312726-2024-00001
• Device Sequence Number: 1
• Product Code: FPA
• 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: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other