MAUDE Adverse Event Report: B BRAUN B BRAUN TUBING; IV TUBING

Lot Number 0061565426

Device Problem Disconnection (1171)

Patient Problem Blood Loss (2597)

Event Date 10/12/2017

Event Type  malfunction  

Event Description

Patient in operating room.B braun iv set tubing disconnected self at the stopcock during the induction of anesthesia, causing loss of medication, and approximately 15-20 ml of blood, which contaminated the stretcher and floor.

• Brand Name: B BRAUN TUBING
• Type of Device: IV TUBING
• Manufacturer (Section D): B BRAUN
• MDR Report Key: 6954557
• MDR Text Key: 89624426
• Report Number: MW5072783
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0061565426
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 21 YR
• Patient Weight: 58