MAUDE Adverse Event Report: LEICA BIOSYSTEMS RICHMOND, INC. BIOPSY PADS 1 X 1.25, BLUE; TISSUE PROCESSING EQUIPMENT

Model Number 3801000

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 01/10/2014

Event Type  Injury  

Event Description

Customer reported that the tissues are under processed when using the foam biopsy pads.This resulted in a re-biopsy of a patient.

Manufacturer Narrative

On (b)(4) 2014 - the supplier was contacted and asked if any changes were made to the foam biopsy pads or to the blue colorant.On (b)(4) 2014 - supplier responded stating the formulation for the foam grade has not changed and many different batches of individual raw material have been used without incident.No change has been made in colorant type or supplier over the past year.Nothing is added to the foam to control static.On (b)(4) 2014, qa (b)(4) tested returned products from customer.The product was visually inspected and compared to a different lot of the same product.The comparison showed all pads were similar in appearance.Ten pads of each lot were placed into beakers with 50mls of 10% nbf.Pads visually appeared to be completely saturated in both beakers.The amount of 10% nbf that remained in the beakers were equivalent.The biopsy pads did not fail and functioned as expected.There have been no other reported incidents with this product of this nature.

• Brand Name: BIOPSY PADS 1 X 1.25, BLUE
• Type of Device: TISSUE PROCESSING EQUIPMENT
• Manufacturer (Section D): LEICA BIOSYSTEMS RICHMOND, INC.; 5205 rt. 12; richmond IL 60071
• Manufacturer Contact: joseph consoli ; 5205 rt. 12; richmond, IL 60071 ; 8156782000
• MDR Report Key: 3624641
• MDR Text Key: 4174534
• Report Number: 1419341-2014-00001
• Device Sequence Number: 1
• Product Code: IEO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/10/2014

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 Model Number: 3801000
• Device Catalogue Number: 3801000
• Device Lot Number: 5713
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/31/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/10/2014
• Initial Date FDA Received: 02/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2013
• 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