MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX; EXTENTION SETS

Model Number	BF100
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504); Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Information received a smiths medical infusion extension sets and disposables|medex extension sets multi line had open line.The rn found leaking at the y-connector on main infusion line.Providers considered it a line break.Cultures drawn and antibiotics given to an oncology patient, due to the invasive line being central line.This patient was considered immune compromised.Cultures cam e back negative.No serious injury occurred but may have occurred with malfunction.

• Brand Name: MEDEX
• Common Device Name: EXTENTION SETS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• MDR Report Key: 11860182
• Report Number: 3012307300-2021-04747
• Device Sequence Number: 19631710
• Product Code: FPA
• UDI-Device Identifier: 10351688511980
• UDI-Public: 10351688511980
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K841882
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2021

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
• Operator of Device: Health Professional
• Device Model Number: BF100
• Device Catalogue Number: BF100
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 05/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 7 MO
• Patient Weight: 10