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

Catalog Number MX4345LM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Air Embolism (1697)

Event Type  Injury  

Manufacturer Narrative

Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.

Event Description

It was reported that "18 post cardiac surgery", the patient experienced an air embolism during use of a medex¿ large bore - hi-flo¿ stopcock.It was observed that the manifold showed no leaks, the stopcock was in the "off" position, and the caps were tightened.Additional information regarding the event and the patient's current condition has been requested, but not yet received.

• 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 km 21.; parque industrial monterrey; apodaca, nl CP 66 603; MX CP 66603
• Manufacturer Contact: jennifer meng ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833078
• MDR Report Key: 6651185
• MDR Text Key: 77887252
• Report Number: 3012307300-2017-01342
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 10351688507594
• UDI-Public: 10351688507594
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MX4345LM
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/05/2017
• 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): Other