MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-20 for STATLOCK PICC PLUS FIXED POST, CRESCENT PAD, INCLUDES SKIN PREP N/A VPPDFP manufactured by Bard Access Systems.
[100657322]
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, at this time, for evaluation. A lot history review (lhr) of jubux364 showed one other similar product complaint(s) from this lot number. The complaints for this lot number (jubux364) have been reported from the same patient. Device has not yet been returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[100657323]
It was reported that the adhesive on the statlock was not holding. It was stated the adhesive did not last a full day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2018-00239 |
| MDR Report Key | 7283641 |
| Date Received | 2018-02-20 |
| Date of Report | 2018-04-12 |
| Date Mfgr Received | 2018-03-23 |
| Device Manufacturer Date | 2017-07-01 |
| Date Added to Maude | 2018-02-20 |
| 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 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| 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 FIXED POST, CRESCENT PAD, INCLUDES SKIN PREP |
| Generic Name | DEVICE, INTRAVASCULAR CATHETER SECUREMENT |
| Product Code | KMK |
| Date Received | 2018-02-20 |
| Returned To Mfg | 2018-03-08 |
| Model Number | N/A |
| Catalog Number | VPPDFP |
| Lot Number | JUBUX364 |
| Operator | LAY USER/PATIENT |
| 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 | 2018-02-20 |