MAUDE Adverse Event Report: SMITHS MEDICAL ASD INC. ULTRA THREE-WAY STOPCOCK W/ MALE LUER LOCK; STOPCOCKS AND MANIFOLDS

Catalog Number MX43660

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/20/2015

Event Type  malfunction  

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 during manipulation of the moveable piece it dislodged from the clear plastic portion of the stopcock.This resulted in a small amount of blood loss.No adverse health outcome resulted from this event.

• Brand Name: ULTRA THREE-WAY STOPCOCK W/ MALE LUER LOCK
• Type of Device: STOPCOCKS AND MANIFOLDS
• 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: michele seliga ; 1265 grey fox rd; st. paul, MN 55112 ; 6516287604
• MDR Report Key: 5180087
• MDR Text Key: 29322327
• Report Number: 2183502-2015-00807
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: MX43660
• Device Lot Number: 2910722
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2015
• 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