MAUDE Adverse Event Report: BD BD POSIFLUSH SF SALINE FLUSH SYRINGE 0.9% PERCENT; SALINE, VASCULAR ACCESS FLUSH

Device Problem Nonstandard Device (1420)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Event Description

Patient was admitted to hospital with sepsis.On (b)(6) 2019 her port was removed because of the staff infection.Patient may have had a bd posiflush sf saline flush syringe as part of a port dressing change kit from the recalled lot numbers affected by the voluntary recall from bd.

• Brand Name: BD POSIFLUSH SF SALINE FLUSH SYRINGE 0.9% PERCENT
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD
• MDR Report Key: 10095917
• MDR Text Key: 192679605
• Report Number: MW5094702
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 50382903065535
• UDI-Public: 50382903065535
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician Assistant
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 56 YR
• Patient Weight: 93