MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-15 for BARD BARCHYSTAR BRACHYTHERAPY APPLICATOR NEEDLE, 18 GAUGE (50/CASE) 918205 manufactured by Bard Reynosa S.a. De C.v. -9617592.
[67657422]
The device was not returned for evaluation. The device history record was reviewed and found nothing that could have caused or contributed to the reported event. The instructions for use state the following: "after use, this product may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and with applicable laws and regulations. Indications: for placement of radioactive seeds in transperineal implant procedures. Caution: using the stylet with excessive force to manipulate lodged seeds may damage the seed. Caution: needles are not intended to penetrate bone. If resistance is encountered, verify needle position. Do not push into bone; this may cause needle to bend or break. Replace needle if cannula, or point, is damaged. " (b)(4). 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
[67657423]
It was reported that there were only four needles instead of five needles in the pouch. The procedure was performed with four needles and all seeds were implanted into the patient. The patient received the intended dosage.
Patient Sequence No: 1, Text Type: D, B5
[69005988]
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. Corrections: evaluation cods, additional mfr narrative. 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
[69005989]
It was reported that there were only four needles instead of five needles in the pouch. The procedure was performed with four needles and all seeds were implanted into the patient. The patient received the intended dosage.
Patient Sequence No: 1, Text Type: D, B5
[73932727]
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. The device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[73932728]
It was reported that there were only four needles instead of five needles in the pouch. The procedure was performed with four needles and all seeds were implanted into the patient. The patient received the intended dosage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2017-00455 |
| MDR Report Key | 6334693 |
| Date Received | 2017-02-15 |
| Date of Report | 2017-07-19 |
| Date of Event | 2017-01-17 |
| Date Mfgr Received | 2017-07-03 |
| Device Manufacturer Date | 2016-07-12 |
| Date Added to Maude | 2017-02-15 |
| 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 REYNOSA S.A. DE C.V. -9617592 |
| Manufacturer Street | BLVD. MONTEBELLO #1 PARQUE INDUSTRIAL COLONIAL |
| Manufacturer City | REYNOSA, TAMAULIPAS |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARD BARCHYSTAR BRACHYTHERAPY APPLICATOR NEEDLE, 18 GAUGE (50/CASE) |
| Generic Name | BRACHYTHERAPY NEEDLE |
| Product Code | IWJ |
| Date Received | 2017-02-15 |
| Catalog Number | 918205 |
| Lot Number | REAT2315 |
| Device Expiration Date | 2019-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD REYNOSA S.A. DE C.V. -9617592 |
| Manufacturer Address | BLVD. MONTEBELLO #1 PARQUE INDUSTRIAL COLONIAL REYNOSA, TAMAULIPAS MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-15 |