MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-30 for BARD? BRACHYSOURCE? I-125 IMPLANT SEEDS IN CARTRIDGES 1251CSF manufactured by Bard Brachytherapy, Inc. -1424526.
[98738390]
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Patient Sequence No: 1, Text Type: N, H10
[98738451]
It was reported that the seeds were not dispensing from the cartridge properly. The complainant reported that the sources were not dropping into the mick and were then getting bunched up and going everywhere. Seeds were reportedly found on the or table and on the floor at the end of the case. The complainant reported that the implant was "completed with full dosage and normal, expected outcome. " one faulty cartridge will be returned with leftover seeds.
Patient Sequence No: 1, Text Type: D, B5
[107622165]
The device was not returned for evaluation. The lot number is unknown; therefore, the device history record could not be reviewed. The instructions for use states the following: "do not unscrew magazines from applicator. Do not exceed the stated capacity of see per cartridge. Do not let seeds drop into the cartridge cavity. Do not use force on seeds; handle gently! " the information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. The device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[107622166]
It was reported that the seeds were not dispensing from the cartridge properly. The complainant reported that the sources were not dropping into the mick and were then getting bunched up and going everywhere. Seeds were reportedly found on the or table and on the floor at the end of the case. The complainant reported that the implant was "completed with full dosage and normal, expected outcome. " one faulty cartridge will be returned with leftover seeds.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2018-00259 |
| MDR Report Key | 7227228 |
| Date Received | 2018-01-30 |
| Date of Report | 2018-05-01 |
| Date of Event | 2018-01-09 |
| Date Mfgr Received | 2018-04-30 |
| Date Added to Maude | 2018-01-30 |
| 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 | BARD? BRACHYSOURCE? I-125 IMPLANT SEEDS IN CARTRIDGES |
| Generic Name | MICK CARTRIDGE |
| Product Code | KXK |
| Date Received | 2018-01-30 |
| Model Number | 1251CSF |
| Catalog Number | 1251CSF |
| 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 | 2018-01-30 |