MAUDE Adverse Event Report: JMS NORTH AMERICA CORPORATION FISTULA NEEDLE SET, WING EATER; NEEDLE, FISTULA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Event Description

A user facility clinic manager reported via fax that the clamp on the device would not clamp line off upon removal of wingeater needles.The was blood loss from access through the tubing until they could quickly just the needle out to he site and hold with gauze.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: FISTULA NEEDLE SET, WING EATER
• Type of Device: NEEDLE, FISTULA
• Manufacturer (Section D): JMS NORTH AMERICA CORPORATION
• MDR Report Key: 17534558
• MDR Text Key: 321151399
• Report Number: MW5141459
• 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: 09/09/2020

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