MAUDE Adverse Event Report: BAIN MEDICAL EQUIPMENT BAIN FISTULA NEEDLE 1 5GX I, FIXED; NEEDLE, FISTULA

Device Problem Dull, Blunt (2407)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Event Description

A dialysis patient reported to clinical service that it took about 3 needles to get her started.The technician tried moving the needle further in and even further out up to the point where the patient started bleeding.It took 3 needles to get it right.She explained how it can cause a scab, the scab takes a while to heal, and can eventually lead to her having to get a new fistula.She said the needles cause bigger holes and take a longer time to heal.(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 1 5GX I, FIXED
• Type of Device: NEEDLE, FISTULA
• Manufacturer (Section D): BAIN MEDICAL EQUIPMENT
• MDR Report Key: 17528781
• MDR Text Key: 321056914
• Report Number: MW5135710
• 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: 12/01/2020

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1