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

Model Number	8 GAUGE X 4
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The handle on the jamshidi needle broke while obtaining core biopsy and jamshidi needle was unable to be removed.Np contacted md, who was unable to remove the needle.Orthopedic surgery was consulted and able to remove the needle.Tip was intact upon removal.Patient followed up with pelvic xr to ensure no remaining needle or needle fragments in hip/pelvis.

• 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: 13151371
• Report Number: 13151371
• Device Sequence Number: 5335685
• Product Code: KNW
• UDI-Device Identifier: 00858690006983
• UDI-Public: (01)00858690006983(17)260730(10)48842
• 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): 12/16/2021
• Report Date (Section F): 12/16/2021

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: Other
• Device Model Number: 8 GAUGE X 4
• Device Catalogue Number: RBN-84
• Device Lot Number: 48842
• 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: 01/04/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/04/2022
• 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: Unknown
• Date Report Sent to FDA: 12/16/2021