MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-05 for ARGYLE 8888160432 manufactured by Cardinal Health, Inc..
[177799151]
Umbilical vessel catheter (uvc) placed on infant following delivery. No insertion complications noted. The procedure note reported blood was withdrawn easily and the catheter flushed without difficulty. Imaging showed the placement in the right hepatic lobe. Repositioning was needed. Staff report the catheter broken after being "pulled back to a low-lying line. " per the procedure note, after insertion the catheter noted to be cracked at the hub, but upon further assessment staff noted the catheter was split in half with only the radiopaque line holding it together. The uvc was removed. Argyle 5fr. Uvc (polyurethane catheter). Secured with suture at 11cm. Dwell time: less than 10 minutes. Manufacturer response for vascular, argyle (per site reporter). Yes, representative is aware and investigating. Informed that catheter is available to return. At the time of this report, it is unknown to this writer if catheter has been returned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9670483 |
| MDR Report Key | 9670483 |
| Date Received | 2020-02-05 |
| Date of Report | 2020-02-03 |
| Date of Event | 2020-01-21 |
| Report Date | 2020-02-03 |
| Date Reported to FDA | 2020-02-03 |
| Date Reported to Mfgr | 2020-02-05 |
| Date Added to Maude | 2020-02-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARGYLE |
| Generic Name | CATHETER, UMBILICAL ARTERY |
| Product Code | FOS |
| Date Received | 2020-02-05 |
| Model Number | 8888160432 |
| Catalog Number | 8888160432 |
| Lot Number | 1906400173 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH, INC. |
| Manufacturer Address | 300 SOUTH RIVERSIDE PLAZA CHICAGO IL 60606 US 60606 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-05 |