MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-20 for BRK? TRANSSEPTAL NEEDLE, 71 CM LENGTH 407200 manufactured by St. Jude Medical, Costa Rica Ltda.
[184464719]
One brk transseptal needle was received for evaluation. The brk needle had been returned coiled and was kinked in multiple locations along its length. The needle tip was fractured and detached. Functional testing was not possible due to the aforementioned damage. The device history record was reviewed to ensure that each manufacturing and inspection operation was performed. Based on the received condition of the device and the information provided, the cause of reported event remains unknown.
Patient Sequence No: 1, Text Type: N, H10
[184464720]
This is event is being reported based on analysis revealing a detached needle tip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008452825-2020-00155 |
| MDR Report Key | 9860039 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2019-12-26 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2019-07-23 |
| Date Added to Maude | 2020-03-20 |
| 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 | STEPHANIE O' SULLIVAN |
| Manufacturer Street | 5050 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 6517565400 |
| Manufacturer G1 | ST. JUDE MEDICAL, COSTA RICA LTDA |
| Manufacturer Street | PARQUE INDUSTRIAL, ZONA FRANCA COYOL S.A. EDIFICIO #44B, CALLE 0, AVENIDA 2, COYOL |
| Manufacturer City | ALAJUELA, COSTA RICA 1897-4050 |
| Manufacturer Country | CS |
| Manufacturer Postal Code | 1897-4050 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BRK? TRANSSEPTAL NEEDLE, 71 CM LENGTH |
| Generic Name | TROCAR |
| Product Code | DRC |
| Date Received | 2020-03-20 |
| Model Number | 407200 |
| Catalog Number | 407200 |
| Lot Number | 7101117 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL, COSTA RICA LTDA |
| Manufacturer Address | PARQUE INDUSTRIAL, ZONA FRANCA COYOL S.A. EDIFICIO #44B, CALLE 0, AVENIDA 2, COYOL ALAJUELA, COSTA RICA 1897-4050 CS 1897-4050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-20 |