MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC; STOPCOCK

Catalog Number MX2311L

Device Problem Improper Flow or Infusion (2954)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/17/2015

Event Type  malfunction  

Event Description

Blood noted to be backing up on central venous pressure line when attempted to flush.Line disconnected.Central line clamped immediately.Estimated blood loss 1-2cc.

• Type of Device: STOPCOCK
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 4549229
• MDR Text Key: 5511515
• Report Number: 4549229
• Device Sequence Number: 1
• Product Code: FMG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 02/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: MX2311L
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/20/2015
• Event Location: Hospital
• Date Report to Manufacturer: 02/26/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 9 YR