MAUDE Adverse Event Report: CALCIUM CHLORIDE 10%, 1000MG/10ML; SYRINGE, PISTON

Lot Number C19413

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  No Answer Provided  

Event Description

There is no pt error.It was noted that 2 boxes look almost identical from the same mfr.The products are calcium chloride 10% injection and heparin lock flush 500 units / 5 ml.Both have similar font and both stickers are yellow.There could be potential for syringe mix-ups when unpacking or storing these medications.(b)(6).(b)(4).

• Brand Name: CALCIUM CHLORIDE 10%, 1000MG/10ML
• Type of Device: SYRINGE, PISTON
• MDR Report Key: 9616226
• MDR Text Key: 176207991
• Report Number: MW5092382
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/21/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: C19413
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1