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

Catalog Number AD21T71WVB-EP/A

Device Problem Fracture (1260)

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

Event Date 07/01/2020

Event Type  Injury  

Manufacturer Narrative

The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.

Event Description

The customer states that during a procedure, the needle detached within a patient.The physician successfully retrieved the foreign body with no additional consequences to the patient.

• Brand Name: MERIT ADVANCE NEEDLE
• Type of Device: IV ADMINISTRATION NEEDLE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 12050063
• MDR Text Key: 257742751
• Report Number: 1721504-2021-00041
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 00884450117286
• UDI-Public: 884450117286
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AD21T71WVB-EP/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: SYRINGE
• Patient Outcome(s): Required Intervention