MAUDE Adverse Event Report: B.BRAUN MEDICAL INC. UNKNOWN; STOPCOCK, I.V. SET

Catalog Number 456020

Device Problems Fluid/Blood Leak (1250); Split (2537)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/02/2016

Event Type  malfunction  

Event Description

When the rn hung ordered iv acetaminophen as ordered on post-op patient.After med infused on alaris iv syringe pump, rn opened med syringe to ns syringe to push nsf through stopcock into med syringe, to hang flush and flush med into baby.When doing so, rn noted there was water on pump and dripping on floor.Upon closer examination, appeared to be a split in stopcock and fluid leaking out (along seam of plastic or is it a crack? unable to tell).Rn unsure of acetaminophen infused in baby or leaked on floor as well.

• Brand Name: UNKNOWN
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): B.BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 6099461
• MDR Text Key: 59771113
• Report Number: 6099461
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 456020
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/08/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1