MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. EXCELSIOR; SALINE, VASCULAR ACCESS FLUSH

Model Number E0100-01

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2022

Event Type  malfunction  

Event Description

Team member reports that when attaching ns syringe 0.9 sodium chloride injection at cleave it would continually pop off.Attempted to screw in the syringe however it would just keep popping off.

• Brand Name: EXCELSIOR
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• MDR Report Key: 15995459
• MDR Text Key: 305603820
• Report Number: 15995459
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 10363807100012
• UDI-Public: (01)10363807100012
• 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: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: E0100-01
• Device Catalogue Number: E0100-01
• Device Lot Number: 3141684
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/01/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/16/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25550 DA
• Patient Sex: Male
• Patient Weight: 104 KG