MAUDE Adverse Event Report: BBRAUN BBRAUN; IV TUBING

Lot Number 0061300407

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/20/2014

Event Type  malfunction  

Event Description

Pt receiving chemotherapy infusion noted to have wet clothing at site of iv tubing laying on arm.Appeared to be associated with injection port.

• Brand Name: BBRAUN
• Type of Device: IV TUBING
• Manufacturer (Section D): BBRAUN; 824 twelth ave.; bethelehem PA 18018 352
• MDR Report Key: 3784135
• MDR Text Key: 19968598
• Report Number: 3784135
• Device Sequence Number: 1
• Product Code: LHI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/26/2014

1 Device was Involved in the Event

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: 0061300407
• Other Device ID Number: 354221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/20/2014
• Event Location: Hospital
• Date Report to Manufacturer: 02/26/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/03/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR