MAUDE Adverse Event Report: THERAGENICS CORPORATION THERASEED PD-103; RADIONUCLIDE BRACHYTHERPY SOURCE

Model Number	ON72X
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon review of the order form, it was confirmed that the units of activity ordered by the customer was converted incorrectly during the order entry process.Theragenics takes pd-103 orders in unist (u).The customer submitted the order in millicuries (mci).The customer service representative incorrectly entered the mci activity as u.The error was not detected during the order entry verification process prior to shipment of the order nor during the customer's order confirmation process.Upon quality review of the received order at the users facility, the discrepancy was detected, and the planned treatment was replaced and rescheduled with the correct activity originally planned.There was no failure or malfunction.The seed order was filled with a higher than requested activity, which would have resulted in a misadministration.
Event or Problem Description
Seed activity for brachytherapy order was entered using the wrong units causing a discrepancy between ordered seed strength and the seed strength that was delivered.

• Brand Name: THERASEED PD-103
• Common Device Name: RADIONUCLIDE BRACHYTHERPY SOURCE
• Manufacturer (Section D): THERAGENICS CORPORATION; 5203 bristol industrial way; buford GA 30518
• MDR Report Key: 6898168
• Report Number: 1037598-2016-00001
• Device Sequence Number: 16318434
• Product Code: KXK
• UDI-Device Identifier: 00813787020846
• UDI-Public: 00813787020846
• Combination Product (Y/N): N
• PMA/510(K) Number: K040339
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial

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: Other Health Care Professional
• Device Model Number: ON72X
• Device Lot Number: 1642F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2016
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 82