MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. B. BRAUN TUBING ; TUBING, FLUID DELIVERY

Lot Number 0061656319

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/10/2019

Event Type  malfunction  

Event Description

Primary rn was hanging chemo on pt and as soon as equashield luer locked, chemo stopped immediately.There was an equashield on tubing prior, but rn replaced a new one before hanging chemo.Therefore, the leak came after the new equashield was replaced.It was not considered a chemo spill because it was less than 5ml.Tubing was changed and a new equashield replaced before therapy started and there was no incident.Pt free from harm.

• Brand Name: B. BRAUN TUBING
• Type of Device: TUBING, FLUID DELIVERY
• Manufacturer (Section D): B. BRAUN MEDICAL INC.
• MDR Report Key: 8464387
• MDR Text Key: 140445024
• Report Number: MW5085305
• Device Sequence Number: 1
• Product Code: FPK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/20/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0061656319
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/28/2019
• 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