MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-08 for STATLOCK SECURMENT DEVICE N/A UNKNOWN manufactured by Bard Access Systems.
[182620193]
The device has not been returned to the manufacturer for evaluation. A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Patient Sequence No: 1, Text Type: N, H10
[182620194]
It was reported that the statlock had "poor" adhesive causing the picc to fall off. It was stated this happened with two statlocks. This report addresses the first statlock.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2019-04091 |
| MDR Report Key | 9563713 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-08 |
| Date of Report | 2020-01-08 |
| Date Mfgr Received | 2019-12-19 |
| Date Added to Maude | 2020-01-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | KELSEY ERICKSON |
| Manufacturer Street | 605 N. 5600 W. |
| Manufacturer City | SALT LAKE CITY UT 84116 |
| Manufacturer Country | US |
| Manufacturer Postal | 84116 |
| Manufacturer Phone | 8015225937 |
| Manufacturer G1 | DAVOL SURGICAL INNOVATIONS -9616067 |
| Manufacturer Street | AVE. ROBERTO FIERRO #6408 PARQUE INDUSTRIAL AEROPUERTO |
| Manufacturer City | CD. JUAREZ, CHIH S.A. DE C.V. 32690 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 32690 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STATLOCK SECURMENT DEVICE |
| Generic Name | STAND, INFUSION |
| Product Code | FOX |
| Date Received | 2020-01-08 |
| Model Number | N/A |
| Catalog Number | UNKNOWN |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD ACCESS SYSTEMS |
| Manufacturer Address | 605 N. 5600 W. SALT LAKE CITY UT 84116 US 84116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-08 |