MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2020-01-07 for DIALYSIS UNKNOWN manufactured by Covidien Mfg Solutions S.a..
[174079480]
Title: the inescapable tunneled cuffed dialysis catheters. A single center experience over one year source: indian j nephrol. 2018 dec; 28(suppl 1): s28? S122. The initial reporter did not provide enough information to determine the specific type of device involved. No product code is available at this time. Where possible, a good faith effort will be performed to obtain this information. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[174079481]
According to literature source of study performed for a duration of one year, a total of 161 patients with chronic kidney disease underwent permcath insertion. A total of 135 patients had the site of permcath insertion in the right internal jugular vein, 22 patients in the left internal jugular vein and 13 patients in the left femoral vein. There were three catheter designs used: staggered tip, split tip and over-the-guidewire. There was one procedure-related death (sudden cardiovascular collapse) reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009211636-2020-00013 |
| MDR Report Key | 9560652 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2020-01-07 |
| Date of Report | 2020-01-07 |
| Date of Event | 2018-12-01 |
| Date Mfgr Received | 2019-12-09 |
| Date Added to Maude | 2020-01-07 |
| 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 | LISA HERNANDEZ |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 2034925563 |
| Manufacturer G1 | COVIDIEN MFG SOLUTIONS S.A. |
| Manufacturer Street | EDIFICIO B20, CALLE #2 |
| Manufacturer City | ALAJUELA 20101 |
| Manufacturer Postal Code | 20101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIALYSIS UNKNOWN |
| Generic Name | CANNULA, A-V SHUNT |
| Product Code | FIQ |
| Date Received | 2020-01-07 |
| Model Number | DIALYSIS UNKNOWN |
| Catalog Number | DIALYSIS UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN MFG SOLUTIONS S.A. |
| Manufacturer Address | EDIFICIO B20, CALLE #2 ALAJUELA 20101 20101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-01-07 |