MAUDE Adverse Event Report: UNKNOWN BAIN FISTULA NEEDLE A5GX1; NEEDLE, FISTULA

Device Problems Device Slipped (1584); Unstable (1667)

Patient Problems Discomfort (2330); Needle Stick/Puncture (2462)

Event Type  Injury  

Event Description

A user facility biomedical technician reported to customer service the safety device is unstable when it is engaged on the bain fistula needle15gx1, fixed.Two (2) users were stuck with contaminated needles.The patients complaint of needle instability and of discomfort.The wings are slippery.The manufacturer has been notified of the complaint.C-754429 (b)(6).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BAIN FISTULA NEEDLE A5GX1
• Type of Device: NEEDLE, FISTULA
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17524734
• MDR Text Key: 321138293
• Report Number: MW5131678
• 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: 03/22/2021

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