MAUDE Adverse Event Report: BECTON DICKINSON & CO POSIFIL SALINE FLUSH 0.990

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Nausea (1970); Vomiting (2144)

Event Date 09/15/2015

Event Type  Injury  

Event Description

Patient seen in interventional radiology for steroid injection of the lumbar spine on (b)(6) 2015.On (b)(6) 2015, patient came to our ed complaining of nausea/vomiting.Found to have positive blood cultures.Patient discharged home on po cipro.On (b)(6), our lab labeled this organism as non-fermenter species, resistant to several antibiotics but sensitive to cipro.After two other patients found to have non-fermenter species in blood cultures, specimens sent to (b)(6) lab, where they were id'd as (b)(6)by mass spectrometry.Repeat blood cultures for this patient on (b)(6)2015 were negative.Reason for use: iv start and iv flush.

• Brand Name: POSIFIL SALINE FLUSH 0.990
• Type of Device: SALINE FLUSH
• Manufacturer (Section D): BECTON DICKINSON & CO
• MDR Report Key: 5364693
• MDR Text Key: 35921988
• Report Number: MW5059286
• Device Sequence Number: 2
• 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
• 4 Devices were Involved in the Event: 1 2 3 4

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
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 73