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

Model Number 900-7842

Device Problem Contamination (1120)

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

Event Type  malfunction  

Event Description

The pharmacy uses the henry schein brand 3 cc syringe sterile trays.After having drawn up 1.5 ml of 0.148 n hydrochloric acid solution into one of these 3 cc syringes, they saw small, black hair-like fiber in the solution."it was not present in vial i drew the solution from and could not have been shed from the sterile alcohol wipes we use, because those wipes are made of white fiber.It appears the contaminant was already present in the syringe.".

• 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
• Manufacturer Contact: jarryd franklin
• MDR Report Key: 18496071
• MDR Text Key: 333002675
• Report Number: 3014312726-2024-00120
• 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: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 900-7842
• Device Lot Number: 02211025
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• Patient Sequence Number: 1