MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2002-01-10 for DOUBLE LUMEN SOFT CENTRAL VENOUS CATHETER TRAY C-SDLMY-401J manufactured by Cook Incorporated.
[212966]
Pt transferred from another hospital with fever of 106 degrees and cyanosis. Admitted to hospital in 2001 to picu, in critical condition, with overwhelming sepsis. Physician attempted central line placement in right femoral vein to get iv access. During procedure, the guidewire kinked on distal end, making passage of cath impossible. Guidewire was cut to accomodate cath and then cath was placed, guided to insertion site, guidewire pulled back, cath inserted, unable to pull out guidewire. Cath removed, guidewire was stuck in subcutaneous tissue. Removed by making a small skin incision to remove the guidewire. On exam the wire was kinked/appears knotted at the end. Pt expired from sepsis and disseminated intravascular coagulopathy two days post. Numerous blood products were transfused.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2002-00006 |
| MDR Report Key | 370685 |
| Report Source | 05,06 |
| Date Received | 2002-01-10 |
| Date of Report | 2001-12-14 |
| Date of Event | 2001-12-02 |
| Date Facility Aware | 2001-12-02 |
| Report Date | 2001-12-13 |
| Date Reported to Mfgr | 2001-12-14 |
| Date Mfgr Received | 2001-12-14 |
| Date Added to Maude | 2002-01-11 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | RITA HARDEN |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DOUBLE LUMEN SOFT CENTRAL VENOUS CATHETER TRAY |
| Generic Name | CENTRAL VENOUS CATHETER |
| Product Code | KRK |
| Date Received | 2002-01-10 |
| Model Number | NA |
| Catalog Number | C-SDLMY-401J |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 359810 |
| Manufacturer | COOK INCORPORATED |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US |
| Baseline Brand Name | DOUBLE LUMEN SOFT CENTRAL VENOUS CATHETER TRAY |
| Baseline Generic Name | NA |
| Baseline Model No | NA |
| Baseline Catalog No | C-SDLMY-401J |
| Baseline ID | NA |
| Baseline Device Family | CENTRAL VENOUS CATHETER |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 36 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-01-10 |