MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SMARTSITE LOW SORBING EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 10013902

Device Problems Disconnection (1171); Device Contamination with Body Fluid (2317)

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

Event Type  malfunction  

Event Description

Rubber tubing disconnected from the plastic piece of the filter tubing after the infusion was completed.Bd smart site low sorbing extensions set 0.2 micron low protein binding filter.Blood got into the tubing therefore was discarded.Fda safety report id # (b)(4).

• Brand Name: SMARTSITE LOW SORBING EXTENSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
• MDR Report Key: 10482253
• MDR Text Key: 205510858
• Report Number: MW5096370
• 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: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/20/2023
• Device Model Number: 10013902
• Device Catalogue Number: 10013902
• Device Lot Number: 20016324
• 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?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 70