MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-12-12 for BRACHY STAR SEED IMPLANT NEEDLE 818205 manufactured by Bard Reynosa S.a. De C.v..
[5201383]
It was reported that the needle broke while in the pt. The needle contained 6 seeds when it broke during the implant. The needle was in the pt when it broke but they were able to retrieve both parts of the needle and the seeds were still in the needle. Per additional info received the needle was being manipulated between the pt and grid with a diddler" (tool used to help guide the needle tip to the target area of the prostate). The needle was in the pt's perinium approximately 1-2 cm when the breakage occurred leaving 2-3 cm protruding outside of the pt's body. The physician was able to grasp the needle with forceps and pull out the broken portion from the pt. The doctor performed a fluoroscopy to ensure that no fragments remained in the pt. No fragments were noted.
Patient Sequence No: 1, Text Type: D, B5
[12701537]
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1018233-2014-00352 |
| MDR Report Key | 4349338 |
| Report Source | 07 |
| Date Received | 2014-12-12 |
| Date of Report | 2014-11-14 |
| Date Mfgr Received | 2014-11-14 |
| Date Added to Maude | 2014-12-31 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHRISTY LEWIS |
| Manufacturer Street | 8195 INDUSTRIAL BLVD. |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | BARD REYNOSA S.A. DE C.V. |
| Manufacturer Street | BLVD MONTEBELLO #1 PARQUE INDUSTRIAL COLONIAL |
| Manufacturer City | REYNOSA, TAMAULIPAS |
| Manufacturer Country | MX |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BRACHY STAR SEED IMPLANT NEEDLE |
| Product Code | IWJ |
| Date Received | 2014-12-12 |
| Model Number | NA |
| Catalog Number | 818205 |
| Lot Number | REYF1142 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD REYNOSA S.A. DE C.V. |
| Manufacturer Address | REYNOSA, TAMAULIPAS MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-12 |