MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC STEREOTACTIC BIOPSY PACK; GENERAL SURGERY TRAY

Catalog Number SAN69STEC7

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/02/2021

Event Type  Injury  

Event Description

During a stereotactic biopsy, the doctor was injecting lidocaine to numb the breast of the patient and when she removed the syringe, the 25g x1 12 needle remained embedded in the patient's breast.The needle had broken off from the hub and remained in the breast.Fda safety report id# (b)(4).

• Brand Name: STEREOTACTIC BIOPSY PACK
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC
• MDR Report Key: 12877916
• MDR Text Key: 281323099
• Report Number: MW5105581
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2023
• Device Catalogue Number: SAN69STEC7
• Device Lot Number: 705150
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White