MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE LUER LOCK DISPOSABLE SYRINGE WITHOUT NEEDLE; SYRINGE, PISTON

Lot Number	200215
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Plastic sliver was found floating in barrel of syringe.Fda safety report id # (b)(4).

• Brand Name: MEDLINE LUER LOCK DISPOSABLE SYRINGE WITHOUT NEEDLE
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.
• MDR Report Key: 10592674
• Report Number: MW5096892
• Device Sequence Number: 13741284
• Product Code: FMF
• UDI-Device Identifier: 10080196310166
• UDI-Public: 10080196310166
• 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): 09/23/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/15/2025
• Device Lot Number: 200215
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1