FDA Adverse Event Death Summary report: N

NORMAL SALINE FLUSH 10ML

MDR report key: 5366157 · Received January 8, 2016

Report

Report Number
MW5059310
Event Type
Death
Date Received
January 8, 2016
Date of Event
September 22, 2015
Report Date
January 8, 2016
Manufacturer
BECTON DICKINSON & CO.
Product Code
NGT
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
WI, US
Reporter Occupation
2

Narratives

Description of Event or Problem · 1

PATIENT CAME TO OUR OUTPATIENT AREA ON (B)(6) 2015 FOR A BLOOD TRANSFUSION. ON (B)(6) 2015, PATIENT CAME TO OUR ED COMPLAINING OF LEG PAIN, PROBABLE CELLULITIS. LACTATE OF 11, REPEAT OF 10.7. POSITIVE BLOOD CULTURES. DIAGNOSED WITH SEVERE SEPSIS. PATIENT DECLINED AGGRESSIVE THERAPY DUE TO UNDERLYING TERMINAL ILLNESS, REQUESTED COMFORT MEASURES ONLY. PATIENT DIED ON (B)(6) 2015. ON (B)(6) 2015 BLOOD CULTURES DRAWN. ON DAY 1 OF GROWTH, SHOWN TO HAVE GRAM NEGATIVE RODS. PATIENT EXPIRED LATER THAT DAY. ON DAY 3 OF GROWTH, ORGANISM IDENTIFIED AS NON-FERMENTER SPECIES. SENT TO MAYO WHEN TWO OTHER PATIENTS HAD SIMILAR ORGANISMS IN BLOOD. IDENTIFIED BY THEM AS ELIZABETHKINGA MENINGOSEPTICA VIA MASS SPECTROMETRY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
14972 NORMAL SALINE FLUSH 10ML NORMAL SALINE FLUSH 10ML NGT BECTON DICKINSON & CO.
14973 NORMAL SALINE FLUSH 10ML NORMAL SALINE FLUSH 10ML NGT BECTON DICKINSON & CO.

Patients

Seq Age Sex Outcome Treatment
1 79 YR Death