MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-16 for STATLOCK PICC PLUS FIXED POST, CRESCENT PAD, INCLUDES SKIN PREP VPPDFP manufactured by Bard Access Systems.
[100480564]
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 manufacturer has received the sample and will be evaluated. Results are expected soon. A lot history review (lhr) of jubux364 showed no other similar product complaint(s) from this lot number.
Patient Sequence No: 1, Text Type: N, H10
[100480565]
It was reported that the adhesive on the statlock is not holding. Complainant alleged the adhesive would not last a full day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2018-00238 |
| MDR Report Key | 7279092 |
| Date Received | 2018-02-16 |
| Date of Report | 2018-04-13 |
| Date Mfgr Received | 2018-03-23 |
| Device Manufacturer Date | 2017-07-01 |
| Date Added to Maude | 2018-02-16 |
| 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 | 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 PICC PLUS FIXED POST, CRESCENT PAD, INCLUDES SKIN PREP |
| Generic Name | DEVICE, INTRAVASCULAR CATHETER SECUREMENT |
| Product Code | KMK |
| Date Received | 2018-02-16 |
| Returned To Mfg | 2018-03-08 |
| 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 | 2018-02-16 |