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

Catalog Number 415122

Device Problems Fluid/Blood Leak (1250); Device Contamination with Body Fluid (2317)

Patient Problem Blood Loss (2597)

Event Date 04/14/2017

Event Type  malfunction  

Event Description

Cap came to charge rn and notified that patient's picc line was bleeding.I went into the patient's room and assessed the site.The insertion site was clean, dry, intact.Infusing into the purple lumen was ivf and there was blood leaking out of the connection site.The b braun cap, patient's gown, bedding, and pants were soiled with blood and ivf.Sterile cap change was performed and site was cleansed.Manufacturer response for carsite luer access device, (brand not provided) (per site reporter): have not heard yet.

• Brand Name: CARESITE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 6559735
• MDR Text Key: 74913629
• Report Number: 6559735
• 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: Patient
• 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: 05/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 415122
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/25/2017
• Event Location: Other
• Date Report to Manufacturer: 04/25/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OTHER, STERILE CAP CHANGE
• Patient Age: 60 YR