MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. 60 ML STRILE SYRINGE; SYRINGE, PISTON

Model Number SYR160010

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Received 60 ml sterile syringes that have lubricant visible to the naked eye on the inside of the syringe barrel.The manufacturer is telling us that this is ok, but i'm afraid that there is enough lubricant in the barrel that some could transfer into medications prepared for iv injection.Fda safety report id# (b)(4).

• Brand Name: 60 ML STRILE SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.
• MDR Report Key: 9933997
• MDR Text Key: 187086942
• Report Number: MW5094066
• Device Sequence Number: 1
• Product Code: FMF
• 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: 04/04/2020

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
• Device Operator: Health Professional
• Device Model Number: SYR160010
• Device Catalogue Number: SYR160010
• Device Lot Number: 180620
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/07/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1