MAUDE Adverse Event Report: MEDEFIL, INC. HEPARIN LOCK FLUSH 500 UNITS/5ML SYRINGES; HEPARIN VASCULAR ACCESS FLUSH

Catalog Number MIH-3335

Device Problem Insufficient Information (3190)

Patient Problem Nausea (1970)

Event Date 12/01/2021

Event Type  malfunction  

Event Description

Department, israel on (b)(6) 2022.Reporter stated that the adverse reactions occurred at hematooncology pediatric unit at (b)(6), israel with heparin lock flush solution, usp, 500 units/5 ml ( 100 units/ml) syringes, manufactured by medefil.During last year of use they had approximately 10-15 patients (with different diagnosis) experiencing nausea and sometimes vomiting after using heparin lock flush syringes.She stated that this happened after the nurse had withdrawn the blood samples in the morning and then they flushed the line with heparin lock flush to prevent the catheter from clotting.Patients age range was 5 - 20 years.Nausea and vomiting is a known hypersesitivity adverse reaction with heparin lock flush (also mentioned in the package insert - copy enclosed).In addition, reporter stated that they had sold more than 1.97 million syringes between 2019-2021 to more than 30 medical centers.No adverse reaction reports has been received for nausea and vomiting.They have received only two complaints about difficulty in operating the syringe due to improper use.

• Brand Name: HEPARIN LOCK FLUSH 500 UNITS/5ML SYRINGES
• Type of Device: HEPARIN VASCULAR ACCESS FLUSH
• Manufacturer (Section D): MEDEFIL, INC.; 250 windy point drive; glendale heights IL 60139 2196
• Manufacturer (Section G): MEDEFIL, INC.; 250 windy point drive; glendale heights IL 60139 3805
• Manufacturer Contact: pradeep aggarwal ; 250 windy point drive; glendale heights, IL 60139-3805 ; 6306824600
• MDR Report Key: 15245292
• MDR Text Key: 305505229
• Report Number: 1423982-2022-00002
• Device Sequence Number: 1
• Product Code: NZW
• UDI-Device Identifier: 6425333335
• UDI-Public: 64253-333-35
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K092491
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: MIH-3335
• Device Lot Number: H121186
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other