MAUDE Adverse Event Report: RANFAC CORP. BONE MARROW BIOPSY NEEDLE, RBN-84; INSTRUMENT, BIOPSY

Model Number	8 GAUGE X 4
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During the patient's bone marrow biopsy procedure, the core needle was inserted into the bone and during removal of the needle the device broke at the plastic attachment to the metal core needle.Several attempts were made to remove it, and ultimately an ortho consult was called.Level 1 pelvic xray pa and lateral were obtained to assess positioning.Ortho was able to remove the needle using sterile pliers.Post-removal x-rays were obtained to ensure no foreign bodies were left in the site.

• Brand Name: BONE MARROW BIOPSY NEEDLE, RBN-84
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): RANFAC CORP.; 30 doherty ave; avon MA 02322
• MDR Report Key: 12786523
• Report Number: 12786523
• Device Sequence Number: 4788290
• Product Code: KNW
• UDI-Device Identifier: 00858690006983
• UDI-Public: (01)00858690006983(17)260122(10)47631
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/08/2021
• Report Date (Section F): 10/08/2021

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
• Operator of Device: Health Professional
• Device Model Number: 8 GAUGE X 4
• Device Catalogue Number: RBN-84
• Device Lot Number: 47631
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/10/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/10/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/08/2021