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

Lot Number 180605

Device Problem Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 12/17/2018

Event Type  malfunction  

Event Description

Multiple instances of medline 10 ml luer lock syringes packaging tearing and thus not able to be opened in a sterile fashion in operating room.

• Brand Name: MEDLINE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8607269
• MDR Text Key: 144956141
• Report Number: 8607269
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/09/2019,12/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 180605
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/09/2019
• Date Report to Manufacturer: 05/14/2019
• Type of Device Usage: N
• Patient Sequence Number: 1