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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDEFIL, INC. HEPARIN FLUSH 500 UNITS/5ML SYRINGES; HEPARIN, VASCULAR ACCESS FLUSH
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MEDEFIL, INC. HEPARIN FLUSH 500 UNITS/5ML SYRINGES; HEPARIN, VASCULAR ACCESS FLUSH Back to Search Results
Device Problems Manufacturing, Packaging or Shipping Problem (2975); Protective Measures Problem (3015)
Patient Problem Insufficient Information (4580)
Event Description
On of our pharmacy technicians was refilling crash cart trays and identified that the calcium chloride 10% 10 ml syringes looked just like our heparin lock flush 500 units/5 ml syringes.Both products are manufactured by medefil, inc.Calcium chloride 10% 10 ml syringes ndc number 64253-900-30; heparin flush 500 units/5 ml syringes, ndc 64253-3335-1.Calcium chloride syringes mainly used in crash cart trays which are kitchecked.We verified that these products were located in separate locations and checked stock for correct product in correct locations, double-checked the barcode scanning to ensure that they scanned as correct products and were not linked inappropriately in kitcheck.We alerted our pharmacy buyers to not purchase calcium chloride 10% syringes from this manufacturer if at all possible.We also discussed these look-alike products at our weekly pharmacy safety huddles and included the information in our pharmacy weekly update to all pharmacy staff.Reporter's recommendations: separate locations for medication storage; ensure proper barcode linking for scanning correct products; use of barcode scanning when stocking/refilling; purchase different manufacturer for calcium chloride syringes if possible (may not always be an option if shortage or contract pricing issues).(b)(6).Submission id: (b)(4).
 
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Brand Name
HEPARIN FLUSH 500 UNITS/5ML SYRINGES
Type of Device
HEPARIN, VASCULAR ACCESS FLUSH
Manufacturer (Section D)
MEDEFIL, INC.
MDR Report Key12934109
MDR Text Key281940262
Report NumberMW5105804
Device Sequence Number2
Product Code NZW
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 09/19/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received12/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Patient Sequence Number1
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