MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-01-03 for STATLOCK UNIVERSAL PLUS LARGE 12-14 F CLAMP ON UNIVERSAL PAD INCLUDES SKIN PREP VUPD1214 manufactured by Bard Access Systems.
[178604606]
The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred. A lot history review (lhr) of judqf441 showed nine other similar product complaint(s) from this lot number. The complaints for this lot number have been reported from the same facility.
Patient Sequence No: 1, Text Type: N, H10
[178604607]
It was reported that statlock (vupd1214) are not sticking properly, and need to be changed more often than usual. It was stated that so far, in the box users have found 4 or 5 that are defective. On 1/3/2020: quantity was updated to 10 not sticking properly. This report addresses the eighth of ten devices.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2020-00007 |
| MDR Report Key | 9547654 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-01-03 |
| Date of Report | 2020-01-03 |
| Date Mfgr Received | 2019-12-12 |
| Device Manufacturer Date | 2019-03-01 |
| Date Added to Maude | 2020-01-03 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KAYLA OLSEN |
| Manufacturer Street | 605 N. 5600 W. |
| Manufacturer City | SALT LAKE CITY UT 84116 |
| Manufacturer Country | US |
| Manufacturer Postal | 84116 |
| Manufacturer Phone | 8015225010 |
| 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 | 3 |
| Brand Name | STATLOCK UNIVERSAL PLUS LARGE 12-14 F CLAMP ON UNIVERSAL PAD INCLUDES SKIN PREP |
| Generic Name | STAND, INFUSION |
| Product Code | FOX |
| Date Received | 2020-01-03 |
| Model Number | NA |
| Catalog Number | VUPD1214 |
| Lot Number | JUDQF441 |
| 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 | 2020-01-03 |