MAUDE Adverse Event Report: BECTON DICKINSON & CO. BD POSIFLUSH PREFILLED SALINE SYRINGES; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306500

Device Problem Nonstandard Device (1420)

Patient Problems Unspecified Infection (1930); Discomfort (2330); No Code Available (3191)

Event Date 05/09/2018

Event Type  Injury  

Event Description

The reporter states that the pt used the saline flush on (b)(6) 2018 and began experiencing issues such as pressure and discomfort in the area.She said that her husband had a dr's appt the following day on the 10th during which the dr told him that he had to have a procedure on his biliary opening.She stated that they also visited the oncologist who found that the pt's white blood cell count was high and prescribed antibiotics.There is also an open recall associated with this device.

• Brand Name: BD POSIFLUSH PREFILLED SALINE SYRINGES
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON & CO.; franklin lakes NJ
• MDR Report Key: 7529773
• MDR Text Key: 108895506
• Report Number: MW5077333
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 05/18/2018

1 Device was Involved in the Event

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 Catalogue Number: 306500
• Device Lot Number: 7293118
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/18/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 115