MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-17 for I-125 QUICKLINK CARTRIDGE (IN PEWTER TRAY), STERILE 1251QCLCE manufactured by Bard Brachytherapy, Inc. -1424526.
[93128786]
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[93128787]
It was reported that the facility received the correct order of seeds with the incorrect implant date. The original order was received and processed on (b)(6) 2017 to have an implant date of (b)(6) 2017 with a seed reference date of (b)(6) 2017. On (b)(6) 2017, a revision request for this order was received from the customer and the implant date was changed to (b)(6) 2017 with the reference date of (b)(6) 2017, per the customer? S request. The new order was printed on (b)(6) 2017 which reflected the revised dates. However; the order that was filled and shipped to the customer had the original (incorrect) dates on the assay cert and labels. The patient received all the seeds as planned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2017-05955 |
| MDR Report Key | 7040654 |
| Date Received | 2017-11-17 |
| Date of Report | 2018-02-01 |
| Date Mfgr Received | 2018-01-29 |
| Date Added to Maude | 2017-11-17 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | AMY GRAVLEY |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | BARD BRACHYTHERAPY, INC. -1424526 |
| Manufacturer Street | 295 EAST LIES ROAD |
| Manufacturer City | CAROL STREAM IL 60188 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60188 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | I-125 QUICKLINK CARTRIDGE (IN PEWTER TRAY), STERILE |
| Generic Name | BRACHY SEEDS |
| Product Code | KXK |
| Date Received | 2017-11-17 |
| Catalog Number | 1251QCLCE |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD BRACHYTHERAPY, INC. -1424526 |
| Manufacturer Address | 295 EAST LIES ROAD CAROL STREAM IL 60188 US 60188 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-17 |