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

Catalog Number MX4312L

Device Problem Improper Flow or Infusion (2954)

Patient Problem Cardiac Arrest (1762)

Event Date 12/25/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6) this device is same and/or similar to a device approved for distribution in the us.

Event 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.

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
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS HEALTHCARE MANUFACTURING SA DE CV; carretera miguel alemán km21.7; parque industrial monterrey; apodaca, nl CP 66 603; MX CP 66603
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7250731
• MDR Text Key: 99308816
• Report Number: 3012307300-2018-00194
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 10351688507754
• UDI-Public: 10351688507754
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: EPINEPHRINE; SEDATION
• Patient Outcome(s): Required Intervention