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

Model Number 09-09SG-0

Device Problems Fluid/Blood Leak (1250); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

A user facility clinic patient care technician (pct) reported via fax that the bain fistula needle causes increased bleeding and pain at needle site.Needles seems to be large for patients with thinner fistulas.When clamping tubing gets stuck outside of clamp and leaking occurs.(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 MEDICAL
• MDR Report Key: 17533236
• MDR Text Key: 321056810
• Report Number: MW5140140
• 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: 08/07/2020

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-0
• Device Lot Number: 201902011899
• Patient Sequence Number: 1