MAUDE Adverse Event Report: ROBERT BUSSE CO., INC. BUSSE HOSPITAL DISPOSABLES; GASTRO-UROLOGY BIOPSY KIT

Model Number	652
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Marrow stuck inside needle, not user friendly, no directions inside packaging, guard doesn't work, device is very difficult to use, does not fit in a normal sharps box that is inside of patient rooms.
Event or Problem Description
Marrow stuck inside needle, not user friendly, no directions inside packaging, guard doesn't work, device is very difficult to use, does not fit in a normal sharps box that is inside of patient rooms.

• Brand Name: BUSSE HOSPITAL DISPOSABLES
• Common Device Name: GASTRO-UROLOGY BIOPSY KIT
• Manufacturer (Section D): ROBERT BUSSE CO., INC.; 75 arkay dr.; hauppauge NY 11788
• MDR Report Key: 15502876
• Report Number: 15502876
• Device Sequence Number: 12724713
• Product Code: PRV
• UDI-Device Identifier: 00849233013278
• UDI-Public: (01)00849233013278
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2022
• Report Date (Section F): 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 652
• Device Catalogue Number: 652
• Device Lot Number: 2220327
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/28/2022
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 09/29/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 09/14/2022