MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-17 for STATLOCK PICC PLUS SLIDING POST, CRESCENT PAD, INCLUDES SKIN PREP N/A VPPCSPCE manufactured by Bard Access Systems.
[142348678]
The information provided by bd 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 bd. The device has not been returned, at this time, to the manufacturer for evaluation. A lot history review (lhr) of juctf145 showed no other similar product complaint(s) from this lot number. Device not yet returned.
Patient Sequence No: 1, Text Type: N, H10
[142348679]
It was reported "damaged statlock. The fixation from the stabilization device to the catheter was desprended. All samples analyzed from the same batch have this issue. The patient lost cvc due to this incident. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2019-00909 |
| MDR Report Key | 8525081 |
| Date Received | 2019-04-17 |
| Date of Report | 2019-07-16 |
| Date of Event | 2019-03-25 |
| Date Mfgr Received | 2019-07-10 |
| Device Manufacturer Date | 2018-06-01 |
| Date Added to Maude | 2019-04-17 |
| 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 | STATLOCK PICC PLUS SLIDING POST, CRESCENT PAD, INCLUDES SKIN PREP |
| Generic Name | STAND, INFUSION |
| Product Code | FOX |
| Date Received | 2019-04-17 |
| Returned To Mfg | 2019-05-22 |
| Model Number | N/A |
| Catalog Number | VPPCSPCE |
| Lot Number | JUCTF145 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-04-17 |