MAUDE Adverse Event Report: SMITHS MEDICAL, INC. HI-FLO FOUR-WAY STOPCOCK W/SWIVEL MALE LUER LOCK; FMG - STOPCOCKS AND MANIFOLDS

Catalog Number MX9341L

Device Problem Detachment Of Device Component (1104)

Patient Problem Blood Loss (2597)

Event Date 02/20/2015

Event Type  Injury  

Event Description

User facility reported while performing extracorporeal membrane oxygenation (ecmo) in the neonatal intensive care unit (nicu), the listed device was in use when the stopcock came apart at the handle and air entered the circuit.The "faulty products" were replaced to remedy the issue.Some blood loss occurred, but it is unknown how much.No permanent patient harm occurred.

Manufacturer Narrative

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

• Brand Name: HI-FLO FOUR-WAY STOPCOCK W/SWIVEL MALE LUER LOCK
• Type of Device: FMG - STOPCOCKS AND MANIFOLDS
• Manufacturer (Section D): SMITHS MEDICAL, INC.; dublin OH
• Manufacturer (Section G): SMITHS MEDICAL; 6250 shier-rings rd.; dublin OH 43016
• Manufacturer Contact: michele seliga ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287604
• MDR Report Key: 4795861
• MDR Text Key: 5818297
• Report Number: 2183502-2015-00361
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/22/2015

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: MX9341L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/22/2015
• Distributor Facility Aware Date: 02/20/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/26/2015
• Initial Date FDA Received: 05/22/2015
• 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