MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-27 for THERASEED PD-103 NA manufactured by Theragenics Corporation.
[87858180]
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.
Patient Sequence No: 1, Text Type: N, H10
[87858181]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037598-2017-00001 |
| MDR Report Key | 6898273 |
| Date Received | 2017-09-27 |
| Date of Report | 2017-04-25 |
| Date of Event | 2017-04-19 |
| Report Date | 2017-04-25 |
| Date Reported to Mfgr | 2017-04-25 |
| Date Mfgr Received | 2017-04-25 |
| Device Manufacturer Date | 2017-04-15 |
| Date Added to Maude | 2017-09-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS MELISA GILCHRIST |
| Manufacturer Street | 5203 BRISTOL INDUSTRIAL WAY |
| Manufacturer City | BUFORD GA 30518 |
| Manufacturer Country | US |
| Manufacturer Postal | 30518 |
| Manufacturer Phone | 7702710233 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | THERASEED PD-103 |
| Generic Name | RADIONUCLIDE BRACHYTHERPY SOURCE |
| Product Code | IWH |
| Date Received | 2017-09-27 |
| Model Number | PD-103 |
| Catalog Number | NA |
| Lot Number | 1714J |
| Device Expiration Date | 2017-05-12 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THERAGENICS CORPORATION |
| Manufacturer Address | 5203 BRISTOL INDUSTRIAL WAY BUFORD GA 30518 US 30518 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-09-27 |