MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-14 for FLEXXICON II KIT 12F X 24CM (SHORT-TERM, DUAL-LUMEN) N/A 5577324 manufactured by Bard Access Systems.
[183766430]
The device has not been returned to the manufacturer for evaluation. 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
[183766431]
It was reported that when opening the kit, the doctor found that a sheath of a introducer needle was damaged. The procedure was completed with another introducer needle which was made by other manufacturer. No patient involvement was reported. Note: japan? S flexxicon ii catheter kit, unlike us? S kit, includes a introducer needle with a sheath (iv catheter).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2020-00073 |
| MDR Report Key | 9588219 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-14 |
| Date of Report | 2020-02-12 |
| Date of Event | 2019-12-13 |
| Date Mfgr Received | 2020-01-31 |
| Date Added to Maude | 2020-01-14 |
| 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 | 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 II KIT 12F X 24CM (SHORT-TERM, DUAL-LUMEN) |
| Generic Name | CATHETER, HEMODIALYSIS, NON-IMPLANTED |
| Product Code | MPB |
| Date Received | 2020-01-14 |
| Returned To Mfg | 2020-01-14 |
| Model Number | N/A |
| Catalog Number | 5577324 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-01-14 |