MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-27 for BARD BRACHYSTAR SEED IMPLANT NEEDLE 818205 manufactured by Bard Brachytherapy, Inc. -1424526.
[87746361]
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
[87746362]
It was reported that the attachment position of the outer needle cannula seemed to be bonded diametrically opposite to the normal position. Because of that, the brachytherapy needle could not go into a suitable hole of the brachytemplait. The device was intended to be used for a procedure but was unable to be used. It is unknown how long the procedure was delayed, but another needle was used for the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2017-05033 |
| MDR Report Key | 6899292 |
| Date Received | 2017-09-27 |
| Date of Report | 2017-10-10 |
| Date of Event | 2016-03-10 |
| Date Mfgr Received | 2017-09-29 |
| Date Added to Maude | 2017-09-27 |
| 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 BRACHYSTAR SEED IMPLANT NEEDLE |
| Generic Name | BRACHY NEEDLE |
| Product Code | IWJ |
| Date Received | 2017-09-27 |
| Returned To Mfg | 2017-08-25 |
| Catalog Number | 818205 |
| 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 | 2017-09-27 |