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U.S. Department of Health and Human Services

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

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CALCIUM CHLORIDE SYRINGE; SYRINGE, PISTON Back to Search Results
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).
 
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Brand Name
CALCIUM CHLORIDE SYRINGE
Type of Device
SYRINGE, PISTON
MDR Report Key13929511
MDR Text Key288172205
Report NumberMW5108548
Device Sequence Number1
Product Code FMF
Combination Product (y/n)Y
Number of Events Reported1
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
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/25/2022
Patient Sequence Number1
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