MAUDE Adverse Event Report: NUCLETRON B.V. ONCENTRA BRACHY; SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED

Model Number	170003-28
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation found that there was no product malfunction with the afterloader system which worked as designed intended and treated the patient as planned.The treatment plan however was incorrect due to use error, which resulted in the complete dose being delivered in a single fraction instead of being distributed over five fractions for a vaginal treatment.The root cause is considered to be an unfortunate combination of use errors.A qualified user will always have to validate and approve the treatment plan to be delivered to a patient before treatment is administered to a patient.
Event or Problem Description
The customer reported that they had a misadministration involving oncentra and flexitron unit.

• Brand Name: ONCENTRA BRACHY
• Common Device Name: SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED
• Manufacturer (Section D): NUCLETRON B.V.; waardgelder 1; veenendaal 3905 TH; NL 3905 TH
• Manufacturer (Section G): NUCLETRON B.V.; waardgelder 1; veenendaal 3905 TH; NL 3905 TH
• Manufacturer Contact: pms ; cornerstone; london road; crawley, west sussex RH10 -9BL ; UK RH10 9BL
• MDR Report Key: 16014803
• Report Number: 9611894-2022-00002
• Device Sequence Number: 7340623
• Product Code: MUJ
• UDI-Device Identifier: 08717213052314
• UDI-Public: 08717213052314
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K132816
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 170003-28
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2022
• Initial Report FDA Received Date: 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2010
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown