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

Catalog Number MIH-3335

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 09/19/2021

Event Type  malfunction  

Event Description

Medefil received a mdr report # (b)(4) on (b)(6) 2022 from fda reporting that 10% calcium chloride injection, usp and heparin lock flush 500 units/5 ml syringes (both manufactured by medefil) looks identical.

Manufacturer Narrative

Medefil inspected the two products.Details of the investigation are given in the attached 'attachment to the mdr report'.Both the products are differentiated from each other.Heparin lock flush label is predominantly yellow in color where as the 10% calcium chloride injection, usp label is predominantly white in color except yellow band where the name of the product is printed (this is similar to the rld label).Tip cap colors for both the products is different - yellow for heparin lock flush and white for 10% calcium chloride injection, usp.The plastic pouch containing the syringes are also different for both the products.Heparin lock flush syringe is in a clear plastic pouch with imprint "do not place the syringe on the sterile field" printed on it, whereas, 10% calcium chloride injection, usp is in a plastic pouch which is yellow colored on the top with product information, and white color on the inside with directions for use.Based on the differences noted above, both products can be differentiated easily from each other.

• 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
• Manufacturer (Section G): MEDEFIL, INC.; 250 windy point drive; glendale heights IL 60139
• Manufacturer Contact: pradeep aggarwal ; 250 windy point drive; glendale heights, IL 60139 ; 6306824600
• MDR Report Key: 13343855
• MDR Text Key: 295491928
• Report Number: 3001677091-2022-00001
• Device Sequence Number: 1
• Product Code: NZW
• UDI-Device Identifier: 6425333335
• UDI-Public: 64253-333-35
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092491
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: MIH-3335
• Date Manufacturer Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1