MAUDE Adverse Event Report: BECTON DICKINSON & CO. NORMAL SALINE FLUSH 10ML

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Death (1802); Pain (1994); Sepsis (2067)

Event Date 09/22/2015

Event Type  Death  

Event Description

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.

• Brand Name: NORMAL SALINE FLUSH 10ML
• Type of Device: NORMAL SALINE FLUSH 10ML
• Manufacturer (Section D): BECTON DICKINSON & CO.
• MDR Report Key: 5366157
• MDR Text Key: 38464567
• Report Number: MW5059310
• Device Sequence Number: 1
• Product Code: NGT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/08/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Other Device ID Number: 8290306500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 79 YR
• Patient Weight: 68