MAUDE Adverse Event Report: BD POSIFLUSH; SALINE, VASCULAR ACCESS FLUSH

Lot Number 6067566

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/30/2016

Event Type  malfunction  

Event Description

During the process of flushing a central line, a prefilled, normal saline syringe started to leak.Upon inspection, a hole was noted in the middle of the syringe.The packaging was inspected and found to be intact.

• Brand Name: POSIFLUSH
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD; 5859 farinon dr. ste. 200; san antonio TX 78249
• MDR Report Key: 5735189
• MDR Text Key: 47711865
• Report Number: 5735189
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Lot Number: 6067566
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/17/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 05/17/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55 YR