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

Model Number	MX9342L
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Patient Problem/Medical Problem (2688)
Date of Event	01/02/2020
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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).
Additional 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
• Common Device Name: 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
• Report Number: 3012307300-2020-01815
• Device Sequence Number: 14241349
• Product Code: FMG
• UDI-Device Identifier: 10351688504166
• UDI-Public: 10351688504166
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/06/2022

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?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2020
• Supplement Date Received by Manufacturer: 07/13/2022; 09/02/2022
• Initial Report FDA Received Date: 03/05/2020
• Supplement Report FDA Received Date: 08/24/2022; 09/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown