MAUDE Adverse Event Report: CALCIUM CHLORIDE SYRINGE; SYRINGE, PISTON

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Description

New presentation of calcium chloride syringe.Medifil is now packaging a calcium chloride syringe that looks similar to heparin flush syringes.Traditionally calcium syringes have always been in a box.Had a near miss when the syringes were mixed in the same bin.(b)(6).Submission id: (b)(4).

• Brand Name: CALCIUM CHLORIDE SYRINGE
• Type of Device: SYRINGE, PISTON
• MDR Report Key: 13929511
• MDR Text Key: 288172205
• Report Number: MW5108548
• Device Sequence Number: 1
• Product Code: FMF
• 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: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1