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 2019-04-08 for SFTCEL-PC RJ 19CM KIT 5534190 manufactured by Bard Access Systems.
[142044203]
As the lot number for the device was not provided, a manufacturing review could not be performed. The sample was returned to the manufacturer for evaluation, the investigation is currently under way.
Patient Sequence No: 1, Text Type: N, H10
[142044204]
It was reported that the catheter was allegedly leaking. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2019-00813 |
| MDR Report Key | 8494042 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-08 |
| Date of Report | 2019-06-17 |
| Date of Event | 2019-03-04 |
| Date Mfgr Received | 2019-05-24 |
| Date Added to Maude | 2019-04-08 |
| 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 | 1625 W 3RD ST. |
| 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 RJ 19CM KIT |
| Generic Name | DIALYSIS CATHETER |
| Product Code | LFJ |
| Date Received | 2019-04-08 |
| Returned To Mfg | 2019-03-22 |
| Model Number | 5534190 |
| Catalog Number | 5534190 |
| Lot Number | UNKNOWN |
| 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 | 2019-04-08 |