MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-03-22 for FLEXXICON DIALYSIS CATHETER KIT 11F X 20CM (SHORT-TERM) (DUAL-LUMEN) N/A 5678200 manufactured by Bard Access Systems.
[140667688]
The manufacturer has received the sample and will evaluate. Results are expected soon. A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Patient Sequence No: 1, Text Type: N, H10
[140667689]
It was reported that the needle was stuck with guidewire, whole set was removed and it was noted the guide wire coil spring was separated from the core wire structure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2019-00629 |
| MDR Report Key | 8444689 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-03-22 |
| Date of Report | 2019-04-03 |
| Date of Event | 2019-02-10 |
| Date Mfgr Received | 2019-03-29 |
| Date Added to Maude | 2019-03-22 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KELSEY ERICKSON |
| Manufacturer Street | 605 N. 5600 W. |
| Manufacturer City | SALT LAKE CITY UT 84116 |
| Manufacturer Country | US |
| Manufacturer Postal | 84116 |
| Manufacturer Phone | 8015225937 |
| Manufacturer G1 | BARD REYNOSA S.A. DE C.V. -9617592 |
| Manufacturer Street | BLVD. MONTEBELLO #1 PARQUE INDUSTRIAL COLONIAL |
| Manufacturer City | REYNOSA, TAMAULIPAS |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEXXICON DIALYSIS CATHETER KIT 11F X 20CM (SHORT-TERM) (DUAL-LUMEN) |
| Generic Name | CATHETER, SUBCLAVIAN |
| Product Code | LFJ |
| Date Received | 2019-03-22 |
| Returned To Mfg | 2019-03-18 |
| Model Number | N/A |
| Catalog Number | 5678200 |
| Lot Number | UNK |
| 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 | 2019-03-22 |