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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD HEPARIN LOCK FLUSH, HEPARIN FLUSH; HEPARIN, VASCULAR ACCESS FLUSH
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BD HEPARIN LOCK FLUSH, HEPARIN FLUSH; HEPARIN, VASCULAR ACCESS FLUSH Back to Search Results
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Patient Involvement (2645)
Event Type  No Answer Provided  
Event Description
Historically at our institution, heparin 10 units/ml flushes have been distributed by our central supply department not pharmacy.Recently a substitution error occurred in which heparin 100 units/ml.Flushes were used to replace heparin 10 units/ml.The wrong flushes were stocked on one of our pediatric inpatient units and fortunately a nurse caught the error prior to utilizing the wrong flush concentration.Since this error occurred, members of pharmacy staff at our institution have had discussions with our central supply leadership.Going forward pharmacy is the only department that will dispense/distribute heparin 100 units/ml.Flushes (strategies will be implemented to prevent central stores from buying/substituting the heparin 100 units/ml flushes in their system) and central stores will distribute/stock the heparin 10 units/ml flushes.At this time, our pharmacy department cannot manage both concentrations of these heparin flushes as there is significant use of the heparin 10 units/ml concentration and would create logistical issues.Additionally, i wanted to share that the substitution error occurred on the part of the manufacturer (bd) and was not recognized by our hospital staff when supply received.(b)(6).
 
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Brand Name
HEPARIN LOCK FLUSH, HEPARIN FLUSH
Type of Device
HEPARIN, VASCULAR ACCESS FLUSH
Manufacturer (Section D)
BD
MDR Report Key8944875
MDR Text Key156320848
Report NumberMW5089436
Device Sequence Number1
Product Code NZW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received08/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator No Information
Type of Device Usage N
Patient Sequence Number1
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