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 2019-11-12 for SFTCEL-PC LJ 23CM KIT 5534230 manufactured by Bard Access Systems.
[166137844]
The lot number for the device was not provided, therefore, the device history records could not be reviewed. The device has been returned to the manufacturer for evaluation. The investigation of the reported event is currently underway.
Patient Sequence No: 1, Text Type: N, H10
[166137845]
It was reported that some time post dialysis catheter placement, the blue luer connector of the dialysis catheter allegedly aspirated air. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2019-03525 |
| MDR Report Key | 9312705 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-11-12 |
| Date of Report | 2019-11-12 |
| Date of Event | 2019-10-10 |
| Date Mfgr Received | 2019-10-16 |
| Date Added to Maude | 2019-11-12 |
| 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 | SFTCEL-PC LJ 23CM KIT |
| Generic Name | DIALYSIS CATHETER |
| Product Code | LFJ |
| Date Received | 2019-11-12 |
| Returned To Mfg | 2019-11-11 |
| Model Number | 5534230 |
| Catalog Number | 5534230 |
| Lot Number | UNKNOWN |
| 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 | 2019-11-12 |