MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-02 for KIT WITH STATLOCK FOR PICC N/A B077801 manufactured by Bard Access Systems.
[143965352]
The device has not been returned to the manufacturer for evaluation. A lot history review (lhr) review is not possible; the manufacturing lot number that was provided is invalid.
Patient Sequence No: 1, Text Type: N, H10
[143965353]
It was reported: lack of fixative dressing in the picc / statlock repair set. Current condition of the patient: no material to repair the dressing. Actions taken in the care facility for patient care: material recovery and exchange made.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3006260740-2019-01257 |
MDR Report Key | 8575114 |
Date Received | 2019-05-02 |
Date of Report | 2019-05-02 |
Date of Event | 2019-02-25 |
Date Mfgr Received | 2019-04-11 |
Date Added to Maude | 2019-05-02 |
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 | 0 |
Brand Name | KIT WITH STATLOCK FOR PICC |
Generic Name | STAND, INFUSION |
Product Code | FOX |
Date Received | 2019-05-02 |
Model Number | N/A |
Catalog Number | B077801 |
Lot Number | 25091845 (INVALID) |
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 | 2019-05-02 |