MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-08-30 for ANGIODYNAMICS * manufactured by Angiodynamics, Inc.
[540676]
Patient arrived at dialysis unit for treatment and while assessing left femoral permcath site, it was found that the blue hub with wings slid down the catheter to the venous/arterial ports with suture intact on wings. The cuff was exposed and catheter slid approximately 2-3 cm out of the exit site. Patient taken to interventional nephrology suite and permcath changeover was initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1040245 |
| MDR Report Key | 756757 |
| Date Received | 2006-08-30 |
| Date of Report | 2006-08-30 |
| Date of Event | 2006-08-23 |
| Date Added to Maude | 2006-09-06 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PHYSICIAN ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANGIODYNAMICS |
| Generic Name | HEMODIALYSIS CATHETER SET |
| Product Code | LFK |
| Date Received | 2006-08-30 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | MADG540 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 744655 |
| Manufacturer | ANGIODYNAMICS, INC |
| Manufacturer Address | 603 QUEENSBURY AVENUE QUEENSBURY NY 12804 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-08-30 |