MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-05 for STATLOCK SECURMENT DEVICE N/A UNKNOWN manufactured by Bard Access Systems.
[182178909]
The device has not been returned to the manufacturer for evaluation. 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
[182178910]
It was reported the catheter securement device for a central venous line detached. The patient had sepsis of the stomach and the patient passed away. On 2/19/2020 - additional information, complainant confirmed the reported event did not cause or contribute to the patient's death. On 2/21/2020 - additional information: the reported event interrupted the infusion of inotrope medications and fluids. The complainant clarified that the statlock detached from the patient's skin and the catheter became dislodged. This occurred when the patient was transferred from a trolley bed to an icu bed. The patient expired one week after the reported statlock detachment. The original catheter was being used to treat the abdominal infection; when it became dislodged, an urgent reinsertion of an internal jugular central line was required due to life-saving medication being given through it. The urgent reinsertion resulted in a lung collapse in the patient which needed further treatment over the week the patient was in intensive care. The patient ultimately died from complications of his abdominal sepsis but his poor clinical course in icu was contributed towards by the lung collapse and the need for several chest drains during that period. The cause of death on the death certificate was multi-organ failure. The death certification is not available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2020-00746 |
| MDR Report Key | 9793473 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-05 |
| Date of Report | 2020-03-05 |
| Date Mfgr Received | 2020-02-11 |
| Date Added to Maude | 2020-03-05 |
| 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 | 3 |
| Brand Name | STATLOCK SECURMENT DEVICE |
| Generic Name | STAND, INFUSION |
| Product Code | FOX |
| Date Received | 2020-03-05 |
| Model Number | N/A |
| Catalog Number | UNKNOWN |
| Lot Number | UNK |
| 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 | 1. Death; 2. Hospitalization; 3. Required No Informationntervention | 2020-03-05 |