FDA Adverse Event Malfunction Summary report: N

THERASEED PD-103

MDR report key: 6898273 · Received September 27, 2017

Report

Report Number: 1037598-2017-00001
Event Type: Malfunction
Date Received: September 27, 2017
Date of Event: April 19, 2017
Report Date: April 25, 2017
Manufacturer: THERAGENICS CORPORATION
Product Code: IWH
UDI-DI: 0081378702860
PMA / PMN Number: K010283
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

UPON REVIEW OF THE ORDER FORM, IT WAS CONFIRMED THAT THE UNITS OF ACTIVITY ORDERED BY THE CUSTOMER WAS ENTERED INCORRECTLY DURING THE ORDER ENTRY PROCESS. THE CUSTOMER REQUESTED 1.7 MCI AND THE ORDER WAS ENTERED AS 1.7 U. THE CUSTOMER SERVICE REPRESENTATIVE DID NOT CONFIRM THE ORDER ACTIVITY WITH THE CUSTOMER PRIOR TO ENTRY. THE ACTIVITY WAS ENTERED LOWER THAN REQUESTED BY THE CUSTOMER. 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 CANCELLED. THERE WAS NO FAILURE OR MALFUNCTION. THE SEED ORDER WAS FILLED WITH A LOWER THAN REQUESTED ACTIVITY, WHICH WOULD HAVE RESULTED IN A MISADMINISTRATION.

Description of Event or Problem · 1

SEED ACTIVITY FOR BRACHYTHERAPY ORDER WAS ENTERED USING THE WRONG UNITS CAUSING A DISCREPANCY BETWEEN THE ORDERED SEED STRENGTH AND THE SEED STRENGTH THAT WAS DELIVERED. THE ERROR WAS DETECTED AT THE USER FACILITY PRIOR TO USE AND THE TREATMENT PLAN AND ORDER WAS CANCELLED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
679320	THERASEED PD-103	RADIONUCLIDE BRACHYTHERPY SOURCE	IWH	THERAGENICS CORPORATION	PD-103	1714J	0081378702860

Patients

Seq	Age	Sex	Outcome	Treatment
1	60 YR		Other