MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-02 for STATLOCK PICC PLUS PIC0220 manufactured by Bard Access Systems, Inc..
[125918940]
Nurse changing picc line dressing and noted that they were unable to close clip on catheter stabling device (statlock).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8032115 |
| MDR Report Key | 8032115 |
| Date Received | 2018-11-02 |
| Date of Report | 2018-10-16 |
| Date of Event | 2018-10-08 |
| Report Date | 2018-10-16 |
| Date Reported to FDA | 2018-10-16 |
| Date Reported to Mfgr | 2018-11-02 |
| Date Added to Maude | 2018-11-02 |
| 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 | 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 | 3 |
| Brand Name | STATLOCK PICC PLUS |
| Generic Name | DEVICE, INTRAVASCULAR CATHETER SECUREMENT |
| Product Code | KMK |
| Date Received | 2018-11-02 |
| Catalog Number | PIC0220 |
| Lot Number | JUCNF434 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD ACCESS SYSTEMS, INC. |
| Manufacturer Address | 605 NORTH 5600 WEST SALT LAKE CITY UT 84116 US 84116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-02 |