MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-19 for CATHETER PASSER 60CM 48409 NA manufactured by Medtronic.
[37442433]
Catheter passer, disposable, 60cm was used in a vp shunt case. The said item used was defective due to excess spacing when the catheter was placed inside.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5059939 |
| MDR Report Key | 5406500 |
| Date Received | 2016-01-19 |
| Date of Report | 2016-01-13 |
| Date of Event | 2016-01-07 |
| Date Added to Maude | 2016-02-03 |
| 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 |
| 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 | CATHETER PASSER 60CM |
| Generic Name | NA |
| Product Code | GYK |
| Date Received | 2016-01-19 |
| Model Number | 48409 |
| Catalog Number | NA |
| Lot Number | D42237 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC |
| Manufacturer Address | MINNEAPOLIS MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-19 |