FDA Adverse Event Summary report: N

SALINE FLUSHES

MDR report key: 13393609 · Received January 28, 2022

Report

Report Number
MW5107064
Date Received
January 28, 2022
Date of Event
December 22, 2021
Report Date
January 28, 2022
Manufacturer
MEDEFIL, INC.
Product Code
NZW
Report Source
Voluntary report
Reporter Occupation
UNKNOWN
Health Professional
*

Narratives

Description of Event or Problem · 0

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).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1649740 SALINE FLUSHES SALINE, VASCULAR ACCESS FLUSH NZW MEDEFIL, INC.
1649741 HEPARIN FLUSHES HEPARIN, VASCULAR ACCESS FLUSH NZW MEDEFIL, INC.

Patients

Seq Age Sex Outcome Treatment
1 Unknown