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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY NORMAL SALINE POSIFLOW FLUSH, HEPARIN 100U/ML POSIFLOW FLUSH; HEPARIN, VASCULAR, ACCESS FLUSH
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BECTON DICKINSON AND COMPANY NORMAL SALINE POSIFLOW FLUSH, HEPARIN 100U/ML POSIFLOW FLUSH; HEPARIN, VASCULAR, ACCESS FLUSH Back to Search Results
Lot Number 729690N
Device Problem Microbial Contamination of Device (2303)
Patient Problems Bacterial Infection (1735); Sepsis (2067); Septic Shock (2068); Complaint, Ill-Defined (2331)
Event Date 06/04/2018
Event Type  Injury  
Event Description
I am currently on tpn, have been stable for the past 8 years and am also a registered nurse.While using the bd brand normal saline/heparin posiflow flushes, i became critically ill.It was determined that i was septic with the bacteria s.Marcescens.This episode of sepsis led to septic shock that required multiple days in the intensive care unit.This is third time i have been septic since (b)(6) despite my central venous catheter being replaced.Testing of my catheter upon removal was negative for bacteria and cultures after each treatment were negative.Upon further research, i became aware that there had been a problem with the same bacteria related to the very flushes i used on a regular basis.None of the flushes i currently have on hand are within the recalled lots which concerns me that the recall hasn't been expanded enough.
 
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Brand Name
NORMAL SALINE POSIFLOW FLUSH, HEPARIN 100U/ML POSIFLOW FLUSH
Type of Device
HEPARIN, VASCULAR, ACCESS FLUSH
Manufacturer (Section D)
BECTON DICKINSON AND COMPANY
MDR Report Key7619036
MDR Text Key111851775
Report NumberMW5077939
Device Sequence Number1
Product Code NZW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/18/2018
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Date FDA Received06/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date10/31/2019
Device Lot Number729690N
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening;
Patient Age50 YR
Patient Weight61
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