MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX¿ LARGE BORE - HI-FLO¿ STOPCOCK; STOPCOCK, I.V. SET

Catalog Number	MX4312L
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	12/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6) this device is same and/or similar to a device approved for distribution in the us.
Event or Problem Description
It was reported that a patient stopped receiving epinephrine during use of a medex¿ large bore - hi-flo¿ stopcock.Initially, the staff thought the connection of the stopcock to the clave had a crack.The stopcock did not connect easily, but there did not appear to be a problem.During use, blood backed up into infusion port when running sedation and epinephrine.Patient was not receiving epinephrine and ended in cardiac arrest requiring cpr for two minutes.It was reported there was no ongoing harm to the patient related to the event.
Additional Manufacturer Narrative
Two devices without their original packaging were returned for evaluation in used condition.Visual inspection found that the smiths medical devices contained adaptors and an extra stopcock not manufactured by smiths medical.Functional testing involved an occlusion test and found all fluid paths to be free and flowed normally.Verification of the adaptors was performed and found that water was not allowed to flow unless connected to another component, as expected.A review of the investigation documents was performed and deemed adequate and correct.Based on the evidence, the root cause was unable to be determined.It was determined that the root cause was not attributable to a smiths medical manufacturing process.

• Brand Name: MEDEX¿ LARGE BORE - HI-FLO¿ STOPCOCK
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7250731
• Report Number: 3012307300-2018-00194
• Device Sequence Number: 1184952
• Product Code: FMG
• UDI-Device Identifier: 10351688507754
• UDI-Public: 10351688507754
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 08/07/2020
• Device Catalogue Number: MX4312L
• Device Lot Number: 3471508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2018
• Supplement Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 02/08/2018
• Supplement Report FDA Received Date: 02/28/2018
• 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: EPINEPHRINE; SEDATION
• Outcome Attributed to Adverse Event: Required Intervention