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

Model Number	16-S20C
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2022
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: SYRINGE, PISTON
• MDR Report Key: 14207583
• Report Number: MW5109364
• Device Sequence Number: 14518332
• Product Code: FMF
• UDI-Device Identifier: 10612479206912
• UDI-Public: 10612479206912
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 04/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/25/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown