MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-20 for STATLOCK SLIDING POST TRICOT CRESCENT PAD INCLUDES SKIN PREP PIC0220CE manufactured by Bard Access Systems.
[120962099]
The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred. A lot history review (lhr) of jubux242 showed no other similar product complaint(s) from this lot number.
Patient Sequence No: 1, Text Type: N, H10
[120962100]
It was reported that a patient developed an extensive erythematosquamous rash exactly on the place where the picc was used. Patient turned out to be allergic to p-tert. Butylcatechol.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2018-02515 |
| MDR Report Key | 7895860 |
| Date Received | 2018-09-20 |
| Date of Report | 2018-09-20 |
| Device Manufacturer Date | 2017-07-01 |
| Date Added to Maude | 2018-09-20 |
| 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 | SHELLY GILBERT |
| Manufacturer Street | 605 N. 5600 W. |
| Manufacturer City | SALT LAKE CITY UT 84116 |
| Manufacturer Country | US |
| Manufacturer Postal | 84116 |
| Manufacturer Phone | 8015225640 |
| 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 | 0 |
| Brand Name | STATLOCK SLIDING POST TRICOT CRESCENT PAD INCLUDES SKIN PREP |
| Generic Name | INTRAVASCULAR CATHETER SECUREMENT DEVICE |
| Product Code | KMK |
| Date Received | 2018-09-20 |
| Catalog Number | PIC0220CE |
| Lot Number | JUBUX242 |
| 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 | 1. Other | 2018-09-20 |