MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-05-21 for VYGON VALUE LIFE PREP KIT AMS-8023CP-1 manufactured by Vygon Usa.
[5925163]
Carefusion maxplus clear needless connector, ref #(b)(4), lot #15028062, exp 02/2020, unscrewed itself from the 10ml prefilled saline syringe that is contained in the vygon value life prep kit (kit for central line access) product code ams-8023cp-1 lot #14l23d, expiration 6/2016. This has happened several times with various patients with the combination of these two products. The maxplus clear needleless connector has not done this with refilled saline syringes that are not contained in this kit that are used in the facility. Diagnosis or reason for use: needless connector for vascular access.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5042849 |
| MDR Report Key | 4802298 |
| Date Received | 2015-05-21 |
| Date of Report | 2015-05-21 |
| Date of Event | 2015-05-19 |
| Date Added to Maude | 2015-05-29 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VYGON VALUE LIFE PREP KIT |
| Generic Name | CENTRAL LINE ACCESS PREP KIT |
| Product Code | OWL |
| Date Received | 2015-05-21 |
| Model Number | AMS-8023CP-1 |
| Lot Number | 14L23D |
| Device Expiration Date | 2016-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYGON USA |
| Manufacturer Address | LANDSDALE PA 19446 US 19446 |
| Brand Name | MAXPLUS CLEAR NEEDLESS CONNECTOR |
| Generic Name | NEEDLESS CONNECTOR |
| Product Code | FPA |
| Date Received | 2015-05-21 |
| Model Number | MP1000-C |
| Lot Number | 15028062 |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-21 |