MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-02 for PERM-CATHETER 8817749001 8817 manufactured by Covidien.
[126516448]
Pt has perm-catheter vascath placed in operating room on (b)(6) 2018 without complications. Pt returned to floor. During the evening hours, the pt was found pulseless. Catheter torn apart found laying on bedside table. Resuscitation efforts failed to revive pt. Left internal jugular vein double lumen permcath dialysis catheter placement with ultrasound and fluoroscopic guidance. A (b)(6) with renal failure due to iga nephropathy requiring hemodialysis. The catheter was secured to the skin of the exit site with 3-0 pds suture. Mastisol and steri-strips were applied. A tegaderm dressing was applied to the catheter exit site. Procedure completed by 1615 on (b)(6) 2018. No evidence of hemo or pneumothorax. Pt returned to room. Family of the pt left pt room during the evening hours. Nursing checks being performed at 2330 and pt discovered to be pale and unresponsive. The proximal end of the catheter with the arterial and venous lines was lying on the bedside table.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8045964 |
| MDR Report Key | 8045964 |
| Date Received | 2018-11-02 |
| Date of Report | 2018-11-01 |
| Date of Event | 2018-10-23 |
| Date Facility Aware | 2018-10-23 |
| Report Date | 2018-11-01 |
| Date Reported to FDA | 2018-11-01 |
| Date Reported to Mfgr | 2018-11-01 |
| Date Added to Maude | 2018-11-07 |
| 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 | 0 |
| 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 | 0 |
| Brand Name | PERM-CATHETER |
| Generic Name | CENTRAL LINE |
| Product Code | KNZ |
| Date Received | 2018-11-02 |
| Model Number | 8817749001 |
| Catalog Number | 8817 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | MANSFIELD MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2018-11-02 |