MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. MERIT ADVANCE; CARDIOVASCULAR NEEDLE

Catalog Number AD18T71W

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/13/2021

Event Type  Injury  

Manufacturer Narrative

The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that during an emergent pericardial drainage on a patient in cardiac arrest due to tamponade, the needle broke when switched from a 20 cc syringe to a 50 cc syringe.The hub of the needle remained in the providers hand while the needle remained in the patient's tissue.

Manufacturer Narrative

The suspect device has been returned for evaluation.The device was examined visually.The complaint is confirmed.The root cause is attributed to rough handling.Excessive forces experienced during use over-stressing the needle, causing the cannula to detach.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.

• Brand Name: MERIT ADVANCE
• Type of Device: CARDIOVASCULAR NEEDLE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• MDR Report Key: 11231073
• MDR Text Key: 228711025
• Report Number: 1721504-2021-00003
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: AD18T71W
• Device Lot Number: H1518034
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/13/2021
• Initial Date FDA Received: 01/26/2021
• Supplement Dates Manufacturer Received: 03/07/2021
• Supplement Dates FDA Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 160