MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-27 for BARD? BRACHYSOURCE? I-125 IMPLANT SEED PS1251LS manufactured by Bard Brachytherapy, Inc. -1424526.
[103805150]
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
[103805171]
It was reported that when the complainant opened the vial to extract the seeds, there was a powdery black substance that spilled from the container. The reported event occurred before patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2018-00961 |
| MDR Report Key | 7373873 |
| Date Received | 2018-03-27 |
| Date of Report | 2018-05-21 |
| Date of Event | 2018-03-07 |
| Date Mfgr Received | 2018-05-16 |
| Device Manufacturer Date | 2018-02-13 |
| Date Added to Maude | 2018-03-27 |
| 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 | 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 SEED |
| Generic Name | SEEDS |
| Product Code | KXK |
| Date Received | 2018-03-27 |
| Returned To Mfg | 2018-03-15 |
| Model Number | PS1251LS |
| Catalog Number | PS1251LS |
| Lot Number | BBCP0024 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-03-27 |