MAUDE Adverse Event Report: BAIN BAIN FISTULA NEEDLE 15GX1, FIXED; NEEDLE, FISTULA

Model Number 09-09SG-O

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

A user facility clinic manager reported via email that multiple access sites are leaking around the bain needle insertion site.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BAIN FISTULA NEEDLE 15GX1, FIXED
• Type of Device: NEEDLE, FISTULA
• Manufacturer (Section D): BAIN
• MDR Report Key: 17527335
• MDR Text Key: 321054525
• Report Number: MW5134268
• Device Sequence Number: 1
• Product Code: FIE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 09-09SG-O
• Device Lot Number: 202002010043
• Patient Sequence Number: 1