MAUDE Adverse Event Report: SYRINGE 20CC; SYRINGE, PISTON

Model Number 16-S20C

Device Problem Fracture (1260)

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

Event Date 04/21/2022

Event Type  malfunction  

Event Description

Syringe had a fracture in barrel "and" could not draw up medication.Syringe had a long crack down the barrel of syringe.Technician had to stop compounding a biologic (tysabri), when it was evident system has not sealed.

• Brand Name: SYRINGE 20CC
• Type of Device: SYRINGE, PISTON
• MDR Report Key: 14207583
• MDR Text Key: 290194462
• Report Number: MW5109364
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 10612479206912
• UDI-Public: 10612479206912
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 16-S20C
• Device Lot Number: CKDH09-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1