MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX STOPCOCK; STOPCOCK, I.V. SET

Model Number MX9342L

Device Problems Mechanical Problem (1384); Infusion or Flow Problem (2964)

Patient Problems Low Blood Pressure/ Hypotension (1914); Patient Problem/Medical Problem (2688)

Event Date 01/02/2020

Event Type  Injury  

Event Description

Information was received indicating that a smiths medical medex stopcocks broke in half causing a "dangerous drop in blood pressure until a new device was located".The reporter indicated that the patient was a vasopressor dependent.The reporter also indicated that spilt was at the contact point (gray/purple connection point between the two yellow stopcock valves).No further adverse events were reported.

Manufacturer Narrative

Other, other text: four samples were received to perform an investigation, three of the samples were unused.It was observed on the used sample that the union between stopcocks was broken.Broken sample was inspected under magnification, an elongation was identified in the broken section on one of the stopcocks and on the other stopcock remaining material was observed.Multiple tests were run on the samples which determined that root cause could not be attributable to manufacturing.The most likely root cause was mishandling during use, as an applied force was required to break the devices.The root cause of the problem was determined to be user interface.This remediation mdr was generated under protocol b10009406, as a result of warning letter (b)(4).

Manufacturer Narrative

Other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#:(b)(4).

• Brand Name: MEDEX STOPCOCK
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis, mn
• Manufacturer (Section G): NULL; parque industrial monterrey; apodaca nl, cp 66603 ; MX 66603
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, mn ; 3833310
• MDR Report Key: 9793455
• MDR Text Key: 182178839
• Report Number: 3012307300-2020-01815
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 10351688504166
• UDI-Public: 10351688504166
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/21/2022
• Device Model Number: MX9342L
• Device Catalogue Number: MX9342L
• Device Lot Number: 3898777
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/04/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening