BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
Report
- Report Number
- 1710034-2019-00630
- Event Type
- Injury
- Date Received
- June 14, 2019
- Date of Event
- April 25, 2019
- Report Date
- July 8, 2019
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FOZ
- UDI-DI
- 30382903835110
- PMA / PMN Number
- K183399
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
DATE OF EVENT: ON (B)(6) 2019.
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTIONS: PMA/510(K)#: K183399.
INVESTIGATION SUMMARY: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLE, BATCH, OR LOT CODE WAS PROVIDED. THIS COMPLAINT WILL BE ENTERED INTO THE COMPLAINT MANAGEMENT SYSTEM AND WILL BE TRACKED & TRENDED FOR FUTURE OCCURRENCES. THE COMPLAINT WAS DEEMED AS MDR REPORTABLE THEREFORE A SUBMISSION WILL BE PERFORMED. SHALL A SAMPLE OR LOT NUMBER BECOME AVAILABLE, THE COMPLAINT WILL BE RE-OPENED AND AN INVESTIGATION WILL TAKE PLACE. THIS COMPLAINT WILL BE CLOSED AT THIS TIME.
IT WAS REPORTED THAT BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INFILTRATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 383511 BATCH NO.: UNKNOWN. IT WAS REPORTED THAT THE IV INFILTRATED THE PATIENT'S RIGHT HAND. PER MEDWATCH: AN IV WAS STARTED FOR A PATIENT WHILE IN THE EMERGENCY DEPARTMENT WHO REQUIRED A BLOOD TRANSFUSION. PUMP HAD BEEN INFUSING AND HAD ALARMED WHEN A HEALTHCARE PROFESSIONAL WAS IN THE ROOM AND NOTED THE INFILTRATION. THE PATIENT DEVELOPED AN IV INFILTRATE AND RIGHT HAND COMPARTMENT SYNDROME REQUIRING A FASCIOTOMY OF THE RIGHT HAND AND FOREARM. PATIENT IS CURRENTLY BEING FOLLOWED BY PLASTIC SURGERY.
IT WAS REPORTED THAT BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INFILTRATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 383511 BATCH NO. UNKNOWN. IT WAS REPORTED THAT THE IV INFILTRATED THE PATIENTS RIGHT HAND. PER MEDWATCH: AN IV WAS STARTED FOR A PATIENT WHILE IN THE EMERGENCY DEPARTMENT WHO REQUIRED A BLOOD TRANSFUSION. PUMP HAD BEEN INFUSING AND HAD ALARMED WHEN A HEALTHCARE PROFESSIONAL WAS IN THE ROOM AND NOTED THE INFILTRATION. THE PATIENT DEVELOPED AN IV INFILTRATE AND RIGHT HAND COMPARTMENT SYNDROME REQUIRING A FASCIOTOMY OF THE RIGHT HAND AND FOREARM. PATIENT IS CURRENTLY BEING FOLLOWED BY PLASTIC SURGERY.
IT WAS REPORTED THAT BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INFILTRATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 383511; BATCH NO. UNKNOWN. IT WAS REPORTED THAT THE IV INFILTRATED THE PATIENTS RIGHT HAND. PER MEDWATCH: AN IV WAS STARTED FOR A PATIENT WHILE IN THE EMERGENCY DEPARTMENT WHO REQUIRED A BLOOD TRANSFUSION. PUMP HAD BEEN INFUSING AND HAD ALARMED WHEN A HEALTHCARE PROFESSIONAL WAS IN THE ROOM AND NOTED THE INFILTRATION. THE PATIENT DEVELOPED AN IV INFILTRATE AND RIGHT HAND COMPARTMENT SYNDROME REQUIRING A FASCIOTOMY OF THE RIGHT HAND AND FOREARM. PATIENT IS CURRENTLY BEING FOLLOWED BY PLASTIC SURGERY.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE EVALUATED BY MFR: A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.
IT WAS REPORTED THAT BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INFILTRATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 383511, BATCH NO.: UNKNOWN. IT WAS REPORTED THAT THE IV INFILTRATED THE PATIENT'S RIGHT HAND. PER MEDWATCH: AN IV WAS STARTED FOR A PATIENT WHILE IN THE EMERGENCY DEPARTMENT WHO REQUIRED A BLOOD TRANSFUSION. PUMP HAD BEEN INFUSING AND HAD ALARMED WHEN A HEALTHCARE PROFESSIONAL WAS IN THE ROOM AND NOTED THE INFILTRATION. THE PATIENT DEVELOPED AN IV INFILTRATE AND RIGHT HAND COMPARTMENT SYNDROME REQUIRING A FASCIOTOMY OF THE RIGHT HAND AND FOREARM. PATIENT IS CURRENTLY BEING FOLLOWED BY PLASTIC SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 495377 | BD NEXIVA¿ CLOSED IV CATHETER SYSTEM | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | UNKNOWN | 30382903835110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |