MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-12-19 for GRIPPER PLUS * manufactured by Smiths Medical Asd, Inc.
[5443590]
Called to bedside to trouble shoot a porta cath that would not flush. Found side port leur lock lying on patient's bed. Side port was open to air.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4506931 |
| MDR Report Key | 4506931 |
| Date Received | 2014-12-19 |
| Date of Report | 2014-12-19 |
| Date of Event | 2014-12-18 |
| Report Date | 2014-12-19 |
| Date Reported to FDA | 2014-12-19 |
| Date Reported to Mfgr | 2015-02-11 |
| Date Added to Maude | 2015-02-11 |
| 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 | 0 |
| 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 | GRIPPER PLUS |
| Generic Name | PORT AND CATHETER |
| Product Code | LKG |
| Date Received | 2014-12-19 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC |
| Manufacturer Address | 10 BOWMAN DR. KEENE, NH 03431 US 03431 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-19 |