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

Catalog Number MX9341L

Device Problem Detachment Of Device Component (1104)

Patient Problem Blood Loss (2597)

Event Date 02/19/2015

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 unk how much.No permanent pt harm occurred.

Manufacturer Narrative

Customer has not yet returned the device to the mfr for device eval.When and if the device becomes available and is returned and evaluated the mfr will file a f/u report detailing the results of the eval.

Manufacturer Narrative

One used product sample was returned for product investigation.The stopcock handle (also known as plug) was disconnected from the stopcock body, causing the device to be non-functional.Visual inspection revealed no moulding issues with the stopcock handle or body.The handle was reassembled on to the stopcock body and tensile tested.The handle disconnected from the stopcock body only after 16.207lbs and 14.983 lbs of force was applied to it.Specification requires the handle to remain seated on the stopcock body up to 12.1lbs of applied force.Therefore, the returned product sample was found to pass specifications for tensile testing.As the returned product sample was returned disassembled, the reported product fault was confirmed; once reassembled the returned sample met specifications and was found to perform as intended.

• Brand Name: HI-FLO FOUR-WAY STOPCOCK W. SWIVEL MALE LUER LOCK
• Type of Device: STOPCOCKS AND MANIFOLDS
• Manufacturer (Section D): SMITHS MEDICAL INC.; dublin OH
• Manufacturer (Section G): SMITHS MEDICAL ASD; 6250 shier-rings road; dublin OH 43016
• Manufacturer Contact: michele seliga ; 1265 grey fox rd; st. paul, MN 55112 ; 6516287604
• MDR Report Key: 4795848
• MDR Text Key: 5818725
• Report Number: 2183502-2015-00362
• 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,Followup
• Report Date: 05/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2015
• 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: 02/19/2015
• Event Location: Hospital
• Date Manufacturer Received: 03/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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