MAUDE Adverse Event Report: ARGON MEDICAL DEVICES ACCUCORE SINGLE ACTION CORE BIOPSY DEVICE 14GA X 3 1/2"(9CM)

Model Number R640914

Device Problem Mechanical Problem (1384)

Patient Problem Needle Stick/Puncture (2462)

Event Date 07/09/2021

Event Type  malfunction  

Manufacturer Narrative

The sample was returned for evaluation.A follow-up report will be submitted once the investigation has been completed.

Event Description

During a breast biopsy when the radiologist remover the needle to extract the biopsy sample.The entire needle came out causing a needle stick to the radiologist.

Event Description

During a breast biopsy when the radiologist remover the needle to extract the biopsy sample the entire needle came out causing a needle stick to the radiologist.

Manufacturer Narrative

A review of one opened sample from the customer found the plunger was broken, confirming the complaint.The most probable cause for the broken plunger is due to excessive drying of the resin material used for hub molding which contributes to brittleness of the stylet plunger.As a corrective action, an automatic shutoff of the molding machine dryer has been implemented to prevent excessive drying of the resin material.The manufacture date of the lot affected in this complaint was prior to the corrective action implementation.

• Brand Name: ACCUCORE SINGLE ACTION CORE BIOPSY DEVICE 14GA X 3 1/2"(9CM)
• Type of Device: ACCUCORE
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• MDR Report Key: 12269222
• MDR Text Key: 266841440
• Report Number: 0001625425-2021-01052
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• PMA/PMN Number: K011270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: R640914
• Device Lot Number: 11344126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other