MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-01 for STATLOCK SECUREMENT DEVICE UNKNOWN manufactured by Bard Access Systems.
[115763032]
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 following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records. Based on a review of this information, the following was concluded: the complaint that the statlock was affecting the patient? S skin was inconclusive due to the sample condition. One photo was provided for investigation. The photo showed gauze adjacent to what appears to be the patient? S arm. An area of redness that resembles the outline of a statlock was observed. A yellowish material was observed on the gauze and in the middle of the area of redness. The statlock was not visible in the photograph. Due to the condition of the sample, the complaint was inconclusive. Potential contributing factors include patient symptoms, reaction, duration of use, and skin preparation technique; however, the exact cause of the event was not determined. 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
[115763033]
It was reported that the patient's skin began to breakdown where the statlock was adhered. More information was requested but not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2018-01907 |
| MDR Report Key | 7741550 |
| Date Received | 2018-08-01 |
| Date of Report | 2018-08-01 |
| Date Mfgr Received | 2018-07-09 |
| Date Added to Maude | 2018-08-01 |
| 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 | 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 SECUREMENT DEVICE |
| Generic Name | INTRAVASCULAR CATHETER SECUREMENT DEVICE |
| Product Code | KMK |
| Date Received | 2018-08-01 |
| Returned To Mfg | 2018-07-09 |
| Catalog Number | UNKNOWN |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 1. Required No Informationntervention | 2018-08-01 |