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

Model Number MX934Z3LM

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 03/23/2020

Event Type  Injury  

Event Description

Information was received indicating that a smiths medical medex manifold snapped at the connection piece.The patient was reported to be receiving vasopressors at the time of break leading to the patient becoming hypotensive.Titration of vasopressors was increased to achieve the ordered mean arterial pressure (map) goals.The unit was changed out and discarded with no further reported adverse effects.

• Brand Name: MEDEX MANIFOLDS
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 10082937
• MDR Text Key: 191830376
• Report Number: 3012307300-2020-04911
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 10351688504159
• UDI-Public: 10351688504159
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MX934Z3LM
• Device Catalogue Number: MX934Z3LM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 76 YR