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

Model Number	MX448HFB
Medical Device Problem Codes	Fluid/Blood Leak (1250); Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Information received a smiths medical infusion extension sets and disposables|medex extension sets single line had leaking of medication.Reported by patients father at 0955 , he called this rn to bedside to notify her that patient is leaking from smoflipid line.Upon assessment, it appeared that lipids were backflowing into line, therefore causing pressure to build.Rn assisted this rn in changing out the filter.Smoflipids were infusing well after change.
Additional Manufacturer Narrative
Other text: one unit was returned for evaluation.The unit was tested and leakage was found from the filter component supplied for use during manufacture of the set.The device was forwarded to our supplier for further testing.The supplier confirmed the leak as well, and noted that the event was likely created due to cracks which could not be contributed to the manufacturing process.The cracks found are often associated with overtightening or alcohol use.A device history review was conducted and found no discrepancies.

• Brand Name: MEDEX
• Common Device Name: EXTENSION SETS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; suite 750; minneapolis, MN 55442
• MDR Report Key: 11916581
• Report Number: 3012307300-2021-05364
• Device Sequence Number: 1374859
• Product Code: FPB
• UDI-Device Identifier: 10351688507457
• UDI-Public: 10351688507457
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K860803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2022

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 Expiration Date: 05/27/2022
• Device Model Number: MX448HFB
• Device Catalogue Number: MX448HFB
• Device Lot Number: 3818593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 06/01/2021
• Supplement Report FDA Received Date: 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown