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

Model Number BAIN-A.V. F-009SG

Device Problems Difficult to Remove (1528); Material Integrity Problem (2978); Physical Resistance/Sticking (4012)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994)

Event Type  Injury  

Event Description

A user facility clinic manager reported via email that they are having issues with the bain fistula needle.They reported needle is not coated with silicone, the needle is sucking up against the wall.They have to pull harder to withdraw needle from the access resulting in blood leak.Patient complain of throbbing pain during treatment.(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: 17535187
• MDR Text Key: 321056899
• Report Number: MW5142086
• 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: 06/26/2020

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?: No
• Device Model Number: BAIN-A.V. F-009SG
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1