MAUDE Adverse Event Report: B.BRAUN MEDICAL, INC.; SET, ADMINISTRATION, INTRAVASCULAR

Lot Number 0061520366

Device Problems Partial Blockage (1065); Break (1069); Fluid/Blood Leak (1250)

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

Event Date 11/02/2016

Event Type  malfunction  

Event Description

Sheath appropriately had b-braun iv extension tubing attached.Saline found infusing in the bed.Extension tubing had come apart at the hub of the iv tubing set.Sheath clotted off.

• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): B.BRAUN MEDICAL, INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 6547131
• MDR Text Key: 74515314
• Report Number: 6547131
• Device Sequence Number: 1
• Product Code: FPA
• 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: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 0061520366
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/25/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 04/25/2017
• 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
• Treatment: NO