MAUDE Adverse Event Report: MICK RADIO-NUCLEAR INSTRUMENTS, INC FLEXI-GUIDE NEEDLE, 15.5G X 25CM (25PC); SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED

Model Number 0912

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/22/2019

Event Type  malfunction  

Event Description

Catheter needle tip for brachy therapy - doctor states "(plastic) tip of catheter broke off, but i saw that it did not go in the patient, but i cannot find it".No x-ray obtained as tip is plastic, per doctor.Upon review, or circulator called soon after, indicated the tip was found in gel outside patient prior to leaving the operating room (or).

• Brand Name: FLEXI-GUIDE NEEDLE, 15.5G X 25CM (25PC)
• Type of Device: SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED
• Manufacturer (Section D): MICK RADIO-NUCLEAR INSTRUMENTS, INC; 521 homestead avenue; mount vernon NY 10550
• MDR Report Key: 8296216
• MDR Text Key: 134713670
• Report Number: 8296216
• Device Sequence Number: 1
• Product Code: JAQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0912
• Device Catalogue Number: 0912
• Device Lot Number: 170307-82
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/31/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 16425 DA