MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES, INC.; GENERAL SURGERY TRAY

Model Number DYNJ32670C

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 07/09/2018

Event Type  malfunction  

Event Description

While using bulb syringe small green particulate material came out of syringe.Appears to be remnants of green material as that which the bulb is made of.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; 1160 s. northpoint blvd.; waukegan IL 60085
• MDR Report Key: 7973938
• MDR Text Key: 124002720
• Report Number: 7973938
• Device Sequence Number: 1
• Product Code: LRO
• 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: 09/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DYNJ32670C
• Device Catalogue Number: DYNJ32670C
• Device Lot Number: 17IK2511
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1