MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-15 for BARD MAGNUM REUSABLE CORE BIOPSY INSTRUMENT MN1820 manufactured by Bard Peripheral Vascular, Inc..
[178748493]
For the 10 reported event, nine lot number were provided, and lot history review. The samples were returned for evaluation. The device was labeled for single use. The company is still investigating the issue at this time. The device is labeled for single use.
Patient Sequence No: 1, Text Type: N, H10
[178748514]
This report summarizes nine malfunctions. A review of the reported malfunctions indicated that model mn1820 biopsy instrument experienced break. These reports were received from various sources. Of the two events, both involved patients with no patient consequences. One female patient was (b)(6) years old, weight was not provided. One male patient's age and weight were not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2020-00302 |
| MDR Report Key | 9591788 |
| Date Received | 2020-01-15 |
| Date of Report | 2020-04-02 |
| Date Mfgr Received | 2020-03-26 |
| Date Added to Maude | 2020-01-15 |
| 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 | 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 | BARD MAGNUM REUSABLE CORE BIOPSY INSTRUMENT |
| Generic Name | BIOPSY INSTRUMENT |
| Product Code | FCG |
| Date Received | 2020-01-15 |
| Model Number | MN1820 |
| Catalog Number | MN1820 |
| Lot Number | REDR2100, REDS0335 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-01-15 |