MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-15 for MAGNUM NEEDLE MN1820 manufactured by Bard Peripheral Vascular, Inc..
[179314563]
The lot number for the malfunctions were provided and a lot history review was performed. The devices were not returned; however images were provided and reviewed. The samples were not returned to the manufacturer for inspection but images were received and reviewed. Based upon the image review, packaging issues were inconclusive for the malfunctions. Based upon the available information, the definitive root cause for this events is unknown. The devices are labeled for single use.
Patient Sequence No: 1, Text Type: N, H10
[179314564]
This report summarizes ten malfunctions. A review of the reported information indicated that model mn1820 biopsy instrument allegedly experienced packaging issues. This information was received from one source. The malfunctions did not involve a patient as there was no patient contact. The patients age, weight, and gender were not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2020-00328 |
| MDR Report Key | 9592527 |
| Date Received | 2020-01-15 |
| Date of Report | 2020-04-03 |
| 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 | MAGNUM NEEDLE |
| Generic Name | BIOPSY INSTRUMENT |
| Product Code | FCG |
| Date Received | 2020-01-15 |
| Model Number | MN1820 |
| Catalog Number | MN1820 |
| Lot Number | RECT2450 |
| 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 |