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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD EXTENSION SET MICROBORE TUBING; SET, ADMINISTRATION, INTRAVASCULAR
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BD EXTENSION SET MICROBORE TUBING; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 20022
Device Problems Crack (1135); Fluid/Blood Leak (1250); Failure to Infuse (2340)
Patient Problem Missed Dose (2561)
Event Date 02/08/2017
Event Type  malfunction  
Event Description
Patient was noted to have a significant drop in activated clotting time which was unchanged with increasing heparin from 20 units/kg/hr to 50 units/kg/hr.Additionally a clot in the mediastinal chest tube formed.Antithrombin iii given as an additional treatment for decreased activated clotting time.The heparin syringe needed to be changed for the 24 hour change.At this time it was noted that the syringe pump tubing had cracked and the heparin was leaking into the floor, not being infused into the patient.New tubing was placed and activated clotting time returned to baseline.
 
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Brand Name
EXTENSION SET MICROBORE TUBING
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BD
5859 farinon drive
suite 200
san antonio TX 78249
MDR Report Key6398593
MDR Text Key69759015
Report Number6398593
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 02/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date12/01/2019
Device Catalogue Number20022
Device Lot Number1088540323326516125054
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/17/2017
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/17/2017
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer02/17/2017
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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