MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX¿ LOGICAL® PRESSURE MONITORING SYSTEM; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	MX9604A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer has not returned the device to the manufacturer for device evaluation.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 leakage of the solution occurred in a medex logical pressure monitoring system.It was noted that misassemble and improper use was ruled out as a probable cause.No injury was reported.
Additional Manufacturer Narrative
Two photos and two partial samples of medex¿ logical® pressure monitoring systems were provided for investigation.A visual inspection was performed and the trigger flush body was found to be deformed.The body and plug of the device were also found to be damage.Functional testing was performed and leakage was observed at the bottom section of the trigger flush.The root cause was determined to be a defective molded component.The root cause for the defective component was unknown.The complaint was confirmed.

• Brand Name: MEDEX¿ LOGICAL® PRESSURE MONITORING SYSTEM
• Common Device Name: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6714686
• Report Number: 3012307300-2017-01484
• Device Sequence Number: 19092628
• Product Code: DRS
• UDI-Device Identifier: 10351688502933
• UDI-Public: 10351688502933
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K820355
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2017

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: No Information
• Device Expiration Date: 09/19/2019
• Device Catalogue Number: MX9604A
• Device Lot Number: 3279117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2017
• Supplement Date Received by Manufacturer: 09/01/2017
• Initial Report FDA Received Date: 07/14/2017
• Supplement Report FDA Received Date: 09/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1