MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2018-02-01 for BARD? BRACHYSOURCE? I-125 IMPLANT SEEDS IN CARTRIDGES PS1251CS manufactured by Bard Brachytherapy, Inc. -1424526.
[98840704]
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
[98840705]
It was reported that the plunger had to be tapped after releasing the first seed in order to lower the second and subsequent seeds. The patient received all seeds as planned. The failings caused re-introductions of needles and sub-optimal control of implant geometry.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2018-00302 |
| MDR Report Key | 7234598 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2018-02-01 |
| Date of Report | 2018-04-19 |
| Date of Event | 2018-01-08 |
| Date Mfgr Received | 2018-04-18 |
| Date Added to Maude | 2018-02-01 |
| 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 | RADIOLOGIC TECHNOLOGIST |
| 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 | 3 |
| Brand Name | BARD? BRACHYSOURCE? I-125 IMPLANT SEEDS IN CARTRIDGES |
| Generic Name | BRACHY CARTRIDGE |
| Product Code | KXK |
| Date Received | 2018-02-01 |
| Returned To Mfg | 2018-02-13 |
| Catalog Number | PS1251CS |
| Lot Number | NA |
| 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 | 1. Required No Informationntervention | 2018-02-01 |