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

Model Number 8 GAUGE X 4

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Pain (1994)

Event Date 09/07/2021

Event Type  malfunction  

Event Description

Patient was planned for bone marrow biopsy today to get diagnostic information about her leukemia to guide therapy.The fellow doctor attempted the left posterior iliac crest biopsy.She was able to collect aspirate for diagnostics and as well as for the clinical trial.The patient reported pain during the blood aspiration process.The procedure was going smoothly and biopsy was collected, however, upon pulling the needle out there was a snarecoil bone marrow biopsy needle malfunction and complete failure of the biopsy guide.The needle is a double lumen and the inner lumen along with handle was pulled out and sleeve was left inside the patient.Multiple attempts to re attached failed.The md fellow tried using a hemostat to pull it out, however the metal was pliable and bendable and ultimately clipped off.Orthopedics team evaluated patient at the bedside, verified needle placement with x-ray and were able to remove the needle by rethreading part of snare coil that had initially detached and then removing.Follow up x-x-ray noted no evidence of left over needle.The wound was cleaned with an alcohol swab and dressed and ice pack was placed.Patient was stable after the procedure was done.No additional procedures noted.

• Brand Name: BONE MARROW BIOPSY NEEDLE, RBN-84
• Type of Device: INSTRUMENT, BIOPSY
• Manufacturer (Section D): RANFAC CORP.; 30 doherty ave; avon MA 02322
• MDR Report Key: 12512275
• MDR Text Key: 272689998
• Report Number: 12512275
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8 GAUGE X 4
• Device Catalogue Number: RBN-84
• Device Lot Number: 47651
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/08/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1