MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-03 for BARD? BRACHYSOURCE? I-125 IMPLANT SEEDS IN CARTRIDGES 1251CSR manufactured by Bard Brachytherapy, Inc. -1424526.
[107527114]
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. Bm (b)(4) is associated with this event. 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
[107527115]
It was reported that the facility received seeds with product code (b)(4) (sales order (b)(4)) that were intended for a different facility, instead of the seeds that were ordered (1251csr and 1251csra - sales order (b)(4)). The initial investigation into the issue indicates that the fedex labels on the outer shipping boxes were switched. The seeds that the facility received ((b)(4)) were reportedly used on the patient and the patient received the correct dosage without impact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2018-01482 |
| MDR Report Key | 7485823 |
| Date Received | 2018-05-03 |
| Date of Report | 2018-07-24 |
| Date of Event | 2018-04-09 |
| Date Mfgr Received | 2018-07-05 |
| Date Added to Maude | 2018-05-03 |
| 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 | YONIC ANDERSON |
| 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 | SEEDS |
| Product Code | KXK |
| Date Received | 2018-05-03 |
| Returned To Mfg | 2018-04-16 |
| Model Number | 1251CSR |
| Catalog Number | 1251CSR |
| Lot Number | UNK |
| 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 | 2018-05-03 |