MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD NORMAL SALINE FLUSH 0.9 PERCENT

Lot Number 409488820

Device Problem Contamination (1120)

Patient Problem Sepsis (2067)

Event Date 12/01/2015

Event Type  Injury  

Event Description

Pt was seen in our ed, transferred to a higher level of care with severe sepsis ((b)(6)).Blood cultures were positive for anaerobic nonfermenter, which our lab identified as stenotrophomonas maltophilia, via chemical analysis.The lab at (b)(6) identified organism as elizabethkingia meningoseptica via molecular analysis.The most recent visit this pt had at our facility was in our outpatient dept for a blood transfusion on (b)(6) 2015.Subsequent similar cases have very little in common except saline flushes.One other flush was stocked on (b)(6) 2015.Dates of use: (b)(6) 2015.Reason for use: iv flushes, iv start.Flushing iv lines, iv starts.

• Brand Name: BD NORMAL SALINE FLUSH 0.9 PERCENT
• Type of Device: BD NORMAL SALINE FLUSH 0.9 PERCENT
• Manufacturer (Section D): BECTON DICKINSON AND CO.
• MDR Report Key: 5366138
• MDR Text Key: 36524257
• Report Number: MW5059301
• 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
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 409488820
• Other Device ID Number: 8290306500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/08/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 83 YR
• Patient Weight: 73