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

Catalog Number	MX5096020MG
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Voluntary medwatch form #mw5067687.Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.
Event or Problem Description
It was reported that during patient use of the medex¿ mangum¿ micro fluid delivery system, the bonded hub was leaking.According to the report the leak was located at the hub that was closest to the intravenous syringe which contained a dopamine infusion.It was reported that lipids "and other ivf?" had backed up into the syringe and was dripping from the hub.It was noted that the crevice under the syringe was full of fluid and a moderate amount of fluid was observed under the intravenous pump as well.According to the reporter, the device was patient use for hours prior to the observed event; however, the full length of time was unknown.No patient injury occurred and no medical intervention was required due to the reported event.

• Brand Name: MEDEX¿ MANGUM¿ MICRO FLUID DELIVERY SYSTEM
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6415260
• Report Number: 3012307300-2017-00679
• Device Sequence Number: 18839741
• Product Code: FPA
• UDI-Device Identifier: 50351688506830
• UDI-Public: 50351688506830
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/17/2017

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: 07/28/2019
• Device Catalogue Number: MX5096020MG
• Device Lot Number: 3248864
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2017
• Initial Report FDA Received Date: 03/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 3500 MEDFUSION® SYRINGE INFUSION PUMP