MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-04 for BARD? BRACHYSOURCE? I-125 IMPLANT SEED PS1251LS manufactured by Bard Brachytherapy, Inc. -1424526.
[107715451]
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. (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. The device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[107715452]
It was reported that the facility received seeds with product codes 1251csr and 1251csra (sales order (b)(4)) that were intended for a different facility instead of the seeds that were ordered (ps1251ls - sales order (b)(4)). The initial investigation into the issue indicates that the fedex labels on the outer shipping boxes were switched. The patient was reportedly unable to undergo the scheduled surgery and an additional surgery was scheduled for a later date. This facility was unable to complete the scheduled procedure for their patient; therefore, an additional surgery was scheduled. However, the seeds alleged against (ps1251ls) were used on a patient at another facility ((b)(6) hospital) per additional information received, the patient's surgery was rescheduled and completed on (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2018-01525 |
| MDR Report Key | 7488238 |
| Date Received | 2018-05-04 |
| Date of Report | 2018-07-13 |
| Date of Event | 2018-04-09 |
| Date Mfgr Received | 2018-07-05 |
| Device Manufacturer Date | 2018-03-19 |
| Date Added to Maude | 2018-05-04 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2018-05-04 |
| Returned To Mfg | 2018-04-30 |
| Model Number | PS1251LS |
| Catalog Number | PS1251LS |
| Lot Number | BBCQ0050 |
| 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 | 2018-05-04 |