MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX® 700 PSI THREE-WAY STOPCOCK WITH MALE LUER LOCK"OFF"HANDLE.; STOPCOCK, I.V. SET

Catalog Number MX4331L

Device Problem Fluid/Blood Leak (1250)

Patient Problems Apnea (1720); Bradycardia (1751); Unspecified Infection (1930); Tachycardia (2095)

Event Date 12/14/2016

Event Type  Injury  

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

It was reported that a (b)(6) patient in the neonatal intensive care unit (nicu) had a leaking medex stopcock.The nicu staff attached the stopcock to the luer locking umbilical catheter, with a saline syringe attached to one empty port and a continuous intravenous infusion attached to the third port.On (b)(6) 2016, the stopcock was found to be leaking, and the stopcock was changed out for a new one.The reporter was unable to confirm whether the product issue and the reported patient infection were related.No further adverse health outcomes were reported.See mfr number: 3012307300-2017-00330.

• Brand Name: MEDEX® 700 PSI THREE-WAY STOPCOCK WITH MALE LUER LOCK"OFF"HANDLE.
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6283260
• MDR Text Key: 65953912
• Report Number: 3012307300-2017-00282
• 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: distributor,foreign,other,use
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 04/28/2019
• Device Catalogue Number: MX4331L
• Device Lot Number: 3192499
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2016
• 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
• Treatment: LUER LOCKING UMBILICAL CATHETER
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 24 DA