MAUDE Adverse Event Report: JMS NEEDLE, FISTULA

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Event Description

A hemodialysis (hd) patient (pt.) was approximately half way through a four hour treatment (tx), when the venous needle became disconnected from the pt and the pt reportedly lost "2 to 3 units of blood'.The blood loss was estimated by the nurse to be approximately 750ml.It was reported that the machine did not alarm.The facility is located in an acute unit at a hospital.The nurse reported that the pt would move his arm during the treatment and had to be reminded to keep it straight.While the nurse was tending to another pt, another nurse noticed the blood coming from the pt's arm.The nurse stated that it is assumed the pt was moving while the nurse was tending to other pts.The pl stated that he didn't feel good and vomited a small amount of bile but did not lose consciousness.The needle site was covered / occluded, treatment was discontinued, and the pt was transferred in the same hospital to the icu where the pt.Was transfused.The nurse reported that the pt.Was stable after the blood transfusion with 2 prbc.The pt has resumed his normal scheduled treatments.The nurse reported that the venous needle was a sysloc needle but did not know the lot and discarded the sample.The nurse also reported that there was no indication of a needle malfunction or defect.Needle: jms sysloc, lot#: unknown, catalog#.Not specified.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: NEEDLE, FISTULA
• Type of Device: NEEDLE, FISTULA
• Manufacturer (Section D): JMS
• MDR Report Key: 17526553
• MDR Text Key: 321061775
• Report Number: MW5133492
• 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: 05/23/2017

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