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

Model Number E0100-01

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 08/11/2022

Event Type  malfunction  

Event Description

While flushing picc line using a pre-filled 10cc saline flush, the wing on the flush snapped 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: 15274619
• MDR Text Key: 298406956
• Report Number: 15274619
• 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: 08/18/2022

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: E0100-01
• Device Catalogue Number: E0100-01
• Device Lot Number: 3141283
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/18/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/23/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 6935 DA
• Patient Sex: Male