MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2020-03-25 for BD NEXIVA? CLOSED IV CATHETER SYSTEM ? SINGLE PORT 24 GA 0.75 IN 383511 manufactured by Becton Dickinson Infusion Therapy Systems Inc..
[188327206]
A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[188327207]
It was reported that an unspecified number of bd nexiva? Closed iv catheter systems? Single port 24 ga 0. 75 in were involved with a serious injury in the form of infiltration during use. No information specifying whether the infiltration resulted in medical intervention/testing has been provided. The following information was provided by the initial reporter: material no. : 383511, batch no. : 9260434. Infiltration was reported. Incident date: (b)(6) 2020. Unknown number affected, but account does have product(s) to be sent back to bd for inspection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1710034-2020-00211 |
| MDR Report Key | 9881145 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-02-23 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2019-09-17 |
| Date Added to Maude | 2020-03-25 |
| 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 | BDX BRETT WILKO |
| Manufacturer Street | 9450 SOUTH STATE STREET |
| Manufacturer City | SANDY UT 84070 |
| Manufacturer Country | US |
| Manufacturer Postal | 84070 |
| Manufacturer Phone | 8015652341 |
| Manufacturer G1 | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. |
| Manufacturer Street | 9450 SOUTH STATE STREET |
| Manufacturer City | SANDY UT 84070 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84070 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD NEXIVA? CLOSED IV CATHETER SYSTEM ? SINGLE PORT 24 GA 0.75 IN |
| Generic Name | INTRAVASCULAR CATHETER |
| Product Code | FOZ |
| Date Received | 2020-03-25 |
| Returned To Mfg | 2020-03-19 |
| Model Number | 383511 |
| Catalog Number | 383511 |
| Lot Number | 9260434 |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. |
| Manufacturer Address | 9450 SOUTH STATE STREET SANDY UT 84070 US 84070 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-25 |