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 2020-02-25 for GLIDEPATH, 14.5F, 23CM, ST, STD KIT 5393230 manufactured by Bard Access Systems.
| Report Number | 3006260740-2020-00614 |
| MDR Report Key | 9750995 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-25 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-01-28 |
| Date Mfgr Received | 2020-01-29 |
| Date Added to Maude | 2020-02-25 |
| 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 | GLIDEPATH, 14.5F, 23CM, ST, STD KIT |
| Generic Name | CATHETER, HEMODIALYSIS, IMPLANTED |
| Product Code | MSD |
| Date Received | 2020-02-25 |
| Returned To Mfg | 2020-02-05 |
| Model Number | 5393230 |
| Catalog Number | 5393230 |
| Lot Number | REDU4305 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD ACCESS SYSTEMS |
| Manufacturer Address | 605 N. 5600 W. SALT LAKE CITY UT 84116 US 84116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-25 |