MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX DOUBLE MALE LUER LOCK; STOPCOCK IV SET

Model Number MX493

Device Problems Fluid/Blood Leak (1250); Insufficient Flow or Under Infusion (2182)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/04/2022

Event Type  malfunction  

Event Description

It was reported via medwatch number (b)(4): patient stated that they noticed wetness in the black bag containing solution bag and pump.No patient injury or adverse affects were reported.

Manufacturer Narrative

The device was unable to be evaluated as it was not returned.If the device is received in the future an evaluation will be performed.The reported event was unable to be confirmed or replicated.A cause of the reported event could not be determined at this time.

Manufacturer Narrative

No lot number was provided; therefore, device history record review could not be performed.D5 is the patient/consumer.

• Brand Name: MEDEX DOUBLE MALE LUER LOCK
• Type of Device: STOPCOCK IV SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): NULL; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15066395
• MDR Text Key: 304022024
• Report Number: 3012307300-2022-13757
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 10351688506917
• UDI-Public: 10351688506917
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954970
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MX493
• Device Catalogue Number: MX493
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Female