MAUDE Adverse Event Report: HOLOGIC, INC BREVERA BREAST BIOPSY DISPOSABLE; INSTRUMENT, BIOPSY

Model Number 2013

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/19/2023

Event Type  Injury  

Manufacturer Narrative

A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.We are currently unable to establish a relationship between the device and the issue reported.The device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed.We are unable to confirm a relationship between the device and the issue reported and a definitive root cause for the reported event could not be determined.The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends.If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.

Event Description

It was reported that on (b)(5), a biopsy procedure was performed with a brevera needle, and during the procedure, the syringe of lidocaine attached to the tubing for delivery during the biopsy leaked around the attachment point of the needle, meaning no lidocaine was getting to the patient.The physician attempted to see the origin of the leak but could not do so without breaking the plastic.The 1st needle was defective, and they had to use a new needle and perform a new incision on the patient's breast.The patient bled more than expected.No additional information available.

• Brand Name: BREVERA BREAST BIOPSY DISPOSABLE
• Type of Device: INSTRUMENT, BIOPSY
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer (Section G): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: ariel lafuente ; 562 parkway; coyol free zone building b24; san jose 20102 ; CR 20102
• MDR Report Key: 18580209
• MDR Text Key: 333733732
• Report Number: 1222780-2024-00028
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 15420045512863
• UDI-Public: (01)15420045512863(17)250522(10)23E23RC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2013
• Device Catalogue Number: NS2013KITUS
• Device Lot Number: 23E23RC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2023
• 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
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Female