MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX MANGUM MICRO FLUID DELIVERY SYSTEM; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	MX448F78MG
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that two sets of magnum tubing would not allow withdraw of fluid from iv bag when spiked.No patient injury reported.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Three (3) product samples were received for evaluation.Visual and functional testing were performed.Visual inspection found on two (2) of the three (3) samples that the yellow part of the valve was assembled inverted.Functional testing performed using the water leak test found that the two (2) of the three (3) samples were also occluded.The root cause of the reported issue was found to be assembly operator error.A quality alert was issued to make assembly operators aware of the correct assembly procedure and an investigation was issued to investigate the cause of the operator skipping the use of an assembly fixture and implement actions.

• Brand Name: MEDEX MANGUM MICRO FLUID DELIVERY SYSTEM
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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; minneapolis, MN 55442
• MDR Report Key: 14279393
• Report Number: 3012307300-2022-07474
• Device Sequence Number: 20383465
• Product Code: FPA
• UDI-Device Identifier: 10351688518842
• UDI-Public: 10351688518842
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2022

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: 03/01/2024
• Device Model Number: MX448F78MG
• Device Catalogue Number: MX448F78MG
• Device Lot Number: 4118555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2022
• Supplement Date Received by Manufacturer: 06/10/2022
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 07/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown