MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-07-03 for COOK CENTRAL VENOUS CATHETER REORDER#C-AMS-250-PED manufactured by Cook Inc.
[3551140]
"a 2. 5 cook central venous catheter was successfully placed into the pt's right femoral vein after several attempts. After successful suturing the line into place, the catheter became dislodged and broke off from the hub and went into the pt's skin and disappeared. The pt was rushed to the operating room for surgery. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3167866 |
| MDR Report Key | 3167866 |
| Date Received | 2008-07-03 |
| Date of Report | 2008-06-09 |
| Date of Event | 2008-06-05 |
| Date Facility Aware | 2008-06-05 |
| Report Date | 2008-06-09 |
| Date Reported to Mfgr | 2008-06-09 |
| Date Added to Maude | 2013-06-14 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOK CENTRAL VENOUS CATHETER |
| Generic Name | VENOUS CATHETER |
| Product Code | OFF |
| Date Received | 2008-07-03 |
| Model Number | REORDER#C-AMS-250-PED |
| Lot Number | F2032466 |
| Device Expiration Date | 2010-01-01 |
| Device Availability | Y |
| Device Age | NA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47405 US 47405 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-07-03 |