MAUDE Adverse Event Report: CALCIUM CHLORIDE 10%; SALINE, VASCULAR ACCESS FLUSH

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Description

While our iv tech was compounding, tech pulled what she thought was calcium chloride 10% syringe for use in a iv piggyback.She thought she was pulling calcium chloride 10% 1000mg/10ml push syringe (ndc 64253-900-30 medefil mfg) to add to 0.9 ns 50ml bag.She was about to scan item in epic before injection and she found she had pulled heparin lock flush 500 usp/5ml (ndc 64253-333-35 medefil mfg.) these 2 medications look identical.Similar packaging and coloring.This never reached patient.Found prior to scan in epic/dispense prep.(b)(6).Submission id: (b)(4).

• Brand Name: CALCIUM CHLORIDE 10%
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• MDR Report Key: 12883981
• MDR Text Key: 281584465
• Report Number: MW5105646
• Device Sequence Number: 1
• Product Code: NZW
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 06/09/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/26/2021
• Patient Sequence Number: 1
• Treatment: EPIC