MAUDE Adverse Event Report: MEDEFIL, INC. HEPARIN FLUSHES; HEPARIN, VASCULAR ACCESS FLUSH

Catalog Number H121350

Device Problems Device Markings/Labelling Problem (2911); Packaging Problem (3007)

Patient Problem Insufficient Information (4580)

Event Date 12/22/2021

Event Description

Medefil inc same looking box: heparin flushes (noc (b)(4)) vs saline flushes (noc (b)(4)).Notified receiving staff.Huddle safety announcement posted for all staff.Mfr/labeler similar labels/packaging.(b)(6).Submission id: (b)(4).

• Brand Name: HEPARIN FLUSHES
• Type of Device: HEPARIN, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): MEDEFIL, INC.
• MDR Report Key: 13393609
• MDR Text Key: 284980878
• Report Number: MW5107064
• Device Sequence Number: 1
• Product Code: NZW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/28/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Catalogue Number: H121350
• Patient Sequence Number: 1