MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-28 for STATLOCK PICC PLUS CRESCENT SLIDING POST N/A PIC0220 manufactured by Bard Access Systems.
[134316273]
The device has not been returned, at this time, 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
[134316274]
It was reported that the "hard plastic part is separating from the foam adhesive. "
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3006260740-2019-00108 |
MDR Report Key | 8283783 |
Date Received | 2019-01-28 |
Date of Report | 2019-01-28 |
Date of Event | 2019-01-07 |
Date Mfgr Received | 2019-01-07 |
Date Added to Maude | 2019-01-28 |
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 | BARD REYNOSA S.A. DE C.V. -9617592 |
Manufacturer Street | BLVD. MONTEBELLO #1 PARQUE INDUSTRIAL COLONIAL |
Manufacturer City | REYNOSA, TAMAULIPAS |
Manufacturer Country | MX |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 0 |
Brand Name | STATLOCK PICC PLUS CRESCENT SLIDING POST |
Generic Name | STAND, INFUSION |
Product Code | FOX |
Date Received | 2019-01-28 |
Model Number | N/A |
Catalog Number | PIC0220 |
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 | 2019-01-28 |