MAUDE Adverse Event Report: RANFAC CORP. RANFAC ASPIRATION NEEDLE; INSTRUMENT, BIOPSY

Model Number 11 GAUGE X 15CM

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/20/2021

Event Type  malfunction  

Event Description

This patient was undergoing a right hip total arthroplasty with bone marrow aspiration.While aspirating the anterior inferior iliac spine of bone marrow aspirate, the jamshidi broke.The surgeon retrieved the piece that broke off and inspected the area to ensure nothing was left behind.The surgeon was confident that no part of the jamshidi was left in the patient.

• Brand Name: RANFAC ASPIRATION NEEDLE
• Type of Device: INSTRUMENT, BIOPSY
• Manufacturer (Section D): RANFAC CORP.; 30 doherty ave; avon MA 02322
• MDR Report Key: 11371845
• MDR Text Key: 233261793
• Report Number: 11371845
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/17/2021,02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11 GAUGE X 15CM
• Device Catalogue Number: RAN-1115
• Device Lot Number: 42659
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/17/2021
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19345 DA
• Patient Weight: 107