MAUDE Adverse Event Report: SMITHS MEDICAL ASD INC MEDEX¿ SMALL BORE STOPCOCKS; STOPCOCK, I.V. SET

Catalog Number MX5311L

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

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

Event Type  malfunction  

Manufacturer Narrative

Additional 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.

Event Description

User facility reported that while in use, the stopcock broke.The nurse had turned the stopcock 180 degrees, heard a snap, and then saw the white portion dislodge from the patient's body with minimal effort.No adverse health outcome occurred, as the stopcock was immediately replaced.

Manufacturer Narrative

The returned stopcock was inspected.Visual investigation showed that the stop on the stopcock plug and the tabs on the top of the body were 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 STOPCOCKS
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): SMITHS MEDICAL ASD INC; 6250 shier rings rd.; dublin OH 43016
• Manufacturer (Section G): SMITHS MEDICAL ASD INC; 6250 shier rings rd.; dublin OH 43016
• Manufacturer Contact: michele seliga ; 1265 grey fox road; st paul 55112 ; 7633833052
• MDR Report Key: 5763563
• MDR Text Key: 48619543
• Report Number: 2183502-2016-01315
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 01/25/2019
• Device Catalogue Number: MX5311L
• Device Lot Number: 3087718
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2016
• 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