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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD HEPARIN LOCK FLUSH SOLUTION, USP; HEPARIN, VASCULAR ACCESS FLUSH

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BD HEPARIN LOCK FLUSH SOLUTION, USP; HEPARIN, VASCULAR ACCESS FLUSH Back to Search Results
Lot Number 129482N
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem Insufficient Information (4580)
Event Date 03/10/2022
Event Type  malfunction  
Event Description
Syringe provided by the manufacturer was missing product label.Syringe should have contained label for heparin lock flush solution 30units/3ml (10units/ml).
 
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Brand Name
HEPARIN LOCK FLUSH SOLUTION, USP
Type of Device
HEPARIN, VASCULAR ACCESS FLUSH
Manufacturer (Section D)
BD
MDR Report Key13757467
MDR Text Key287249861
Report NumberMW5108112
Device Sequence Number1
Product Code NZW
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 03/10/2022
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? Yes
Device Expiration Date03/31/2023
Device Lot Number129482N
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/11/2022
Patient Sequence Number1
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