MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-20 for MAGNUM NEEDLE MN1820 manufactured by Bard Peripheral Vascular, Inc..
[180180080]
The lot number was provided so a review of the device history records was performed. The sample was not returned to bd for evaluation. Therefore, the investigation of the reported event is inconclusive. Based upon the available information, the definitive root cause for this event is unknown. The device is labeled for single use. (expiry date 08/2021).
Patient Sequence No: 1, Text Type: N, H10
[180180081]
It was reported that during a prostate biopsy procedure, the user allegedly experienced a needle stick. It was further reported that the procedure was completed with another device. There were no further reported complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2020-01084 |
| MDR Report Key | 9732838 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-20 |
| Date of Report | 2020-02-20 |
| Date Mfgr Received | 2020-01-27 |
| Date Added to Maude | 2020-02-20 |
| 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 | JUDITH LUDWIG |
| Manufacturer Street | 1415 W. 3RD STREET |
| Manufacturer City | TEMPE AZ 85281 |
| Manufacturer Country | US |
| Manufacturer Postal | 85281 |
| Manufacturer Phone | 4803032689 |
| Manufacturer G1 | BARD REYNOSA S.A. DE C.V. |
| Manufacturer Street | BLVD MONTEBELLO #1 PARQUE INDUSTRIAL COLONIAL |
| Manufacturer City | REYNOSA TAMAULIPAS 88780 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88780 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAGNUM NEEDLE |
| Generic Name | BIOPSY INSTRUMENT |
| Product Code | FCG |
| Date Received | 2020-02-20 |
| Model Number | MN1820 |
| Catalog Number | MN1820 |
| Lot Number | REDX1626 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD PERIPHERAL VASCULAR, INC. |
| Manufacturer Address | 1625 W 3RD ST. TEMPE AZ 85281 US 85281 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-20 |