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

Catalog Number MX9341L

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 02/15/2015

Event Type  Injury  

Event Description

User facility reported that during use the stopcock came apart at the handle allowing air to enter the circuit.Information on medical intervention taken as a result of this event has been requested, but to date no further information provided.

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.

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 and body were reassembled and tensile tested.The handle disconnected from the stopcock body only after (b)(6) and (b)(6) of force was applied.Specification requires the handle to remain seated on the stopcock body up to (b)(6) 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 observed to perform as intended.

• Brand Name: HI-FLO FOUR-WAY STOPCOCK W/ MALE LUER LOCK
• Type of Device: FMG - STOPCOCKS AND MANIFOLDS
• Manufacturer (Section D): SMITHS MEDICAL MD, 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: 4795512
• MDR Text Key: 5855568
• Report Number: 2183502-2015-00346
• 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: 05/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2015
• 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: 05/21/2015
• Distributor Facility Aware Date: 02/15/2015
• 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