MAUDE Adverse Event Report: UNKNOWN AVF 15G X 1" MGP, BE, CL, 12" TUBING; NEEDLE, FISTULA

Catalog Number D9-2005MGP

Device Problem Difficult to Remove (1528)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported after a successful treatment the patient care technician (pct) attempted to remove the avf 15g from the patient.They were able to see it but could not remove it any further with the needles taped down to the arm in place.911 was called and the patient was taken to the er.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: AVF 15G X 1" MGP, BE, CL, 12" TUBING
• Type of Device: NEEDLE, FISTULA
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17531384
• MDR Text Key: 321315875
• Report Number: MW5138299
• 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: 01/25/2022

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 Catalogue Number: D9-2005MGP
• Device Lot Number: 210303F3
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1