MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. DUALCAP; PAD, ALCOHOL, DEVICE DISINFECTANT

Lot Number A002686, A002685

Device Problems Break (1069); Physical Resistance/Sticking (4012)

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

Event Date 07/02/2019

Event Type  malfunction  

Event Description

The foam inside the device is breaking and attaching to the iv tubing and/or needleless connector.The foam is able to get inside the uv tubing to possibly be injected into the patient's bloodstream.Manufacturer response for alcohol cap, dualcap (per site reporter).The manufacturer is meeting with representatives from our facility soon.

• Brand Name: DUALCAP
• Type of Device: PAD, ALCOHOL, DEVICE DISINFECTANT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 west merit pkwy; south jordan UT 84095
• MDR Report Key: 8965057
• MDR Text Key: 156630782
• Report Number: 8965057
• Device Sequence Number: 1
• Product Code: LKB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: A002686, A002685
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/02/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/05/2019
• Type of Device Usage: N
• Patient Sequence Number: 1