MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC MERIT CUSTOM KIT

Catalog Number K09-02334N

Device Problem Air Leak (1008)

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

Event Date 08/11/2016

Event Type  malfunction  

Manufacturer Narrative

One device was returned for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The user reported that the purchased drip chamber in their kit is running out of contrast before the bottle is empty.No air was injected into the patient.

Manufacturer Narrative

One device was returned for evaluation.The device was examined visually and simulated use testing was performed.The complaint is confirmed.The root cause is attributed to the manufacturing process.The device history record and complaint database could not be reviewed as the lot of the returned unit was not confirmed.Corrective actions are in place.

• Brand Name: MERIT CUSTOM KIT
• Type of Device: CUSTOM KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC; 1600 west merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC; 1600 west merit parkway; south jordan UT 84095
• Manufacturer Contact: casey hughes, ms, cqe ; 1600 west merit parkway; south jordan, UT 84095 ; 8013164932
• MDR Report Key: 5913517
• MDR Text Key: 53458623
• Report Number: 1721504-2016-00169
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K913161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: K09-02334N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2016
• 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