MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-22 for STATLOCK PICC PLUS SLIDING POST, CRESCENT PAD, INCLUDES SKIN PREP VPPCSPCE manufactured by Bard Access Systems.
[103428969]
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) review is not possible, as no manufacturing lot number has been provided by the complainant.
Patient Sequence No: 1, Text Type: N, H10
[103428970]
It was reported that a nurse found the retainer of the statlock was spontaneously detached from the pad, which caused the catheter to come out approximately by 8cm from the patient's body. Allegedly, the nurse noticed it when checking the insertion site after the patient moved from his wheelchair to his bed. When the powerpicc was implanted on (b)(6) 2018, the statlock used for the operation was not from the same package as the powerpicc, but one sold as a single item. No patient injury has been reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2018-00494 |
| MDR Report Key | 7361981 |
| Date Received | 2018-03-22 |
| Date of Report | 2018-05-17 |
| Date of Event | 2018-02-16 |
| Date Mfgr Received | 2018-04-03 |
| Date Added to Maude | 2018-03-22 |
| 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 | 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 SLIDING POST, CRESCENT PAD, INCLUDES SKIN PREP |
| Generic Name | DEVICE, INTRAVASCULAR CATHETER SECUREMENT |
| Product Code | KMK |
| Date Received | 2018-03-22 |
| Returned To Mfg | 2018-03-15 |
| Catalog Number | VPPCSPCE |
| Lot Number | UNK |
| 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 | 2018-03-22 |