MAUDE Adverse Event Report: SMITHS MEDICAL ASD INC MEDEX SMALL BORE 3-WAY STOPCOCK WITH SWIVEL MALE LUER; STOPCOCK, I.V. SET

Catalog Number MX5311L

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The device is currently being evaluated; the manufacturer will file a follow-up report detailing the results of the evaluation once it is completed.

Event Description

It was reported the turn piece of the 3 way stopcock fell out of the housing.Medication was wasted.No adverse patient health outcome was reported.See mfr: 2183502-2016-01478, 2183502-2016-01482.

Manufacturer Narrative

The returned stopcock was inspected.Visual investigation showed that the stop on the stopcock plug was damaged.The plug stop and the tabs on the stopcock body, are to control the handle positions around the stopcock as an intuitive design for a 3-way stopcock for fluid flow direction.Based on the condition, the clinical person using the product violated the stop and turned the handle in a direction not intended based on its design.Based on the review of the returned unit, the unit had been violated thus indicating the customer misused the product.(b)(4).

• Brand Name: MEDEX SMALL BORE 3-WAY STOPCOCK WITH SWIVEL MALE LUER
• 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: lisa perz ; 1265 grey fox road; st paul, MN 55112 ; 7633833074
• MDR Report Key: 5792343
• MDR Text Key: 49495503
• Report Number: 2183502-2016-01479
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: MX5311L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/30/2016
• 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: Initial
• Patient Sequence Number: 1