BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT 20 GA 1.25 IN
Report
- Report Number
- 1710034-2023-00698
- Event Type
- Malfunction
- Date Received
- June 19, 2023
- Date of Event
- May 24, 2023
- Report Date
- August 7, 2023
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FOZ
- UDI-DI
- 30382903835172
- PMA / PMN Number
- K102520
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
H.6. INVESTIGATION SUMMARY: A PHYSICAL SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION BUT BD WAS PROVIDED WITH A PHOTO AND VIDEO OF THE ISSUE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT, 2173237, AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER REVIEWED THE PROVIDED PHOTO AND VIDEO. IN THE VIDEO THE ENGINEER IDENTIFIED THAT THE OPERATOR WAS HAVING DIFFICULTY DISENGAGING THE NEEDLE. DURING THIS ATTEMPT, THERE WAS A NOTICEABLE RESISTANCE, AND A SCRATCHY NOISE. THEREFORE, BASED OFF THE PROVIDED VIDEO AND PHOTO THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. UNFORTUNATELY, WITHOUT A PHYSICAL SAMPLE AVAILABLE FOR TESTING THE ENGINEER COULD NOT DETERMINE A DEFINITIVE ROOT CAUSE FOR THIS ISSUE. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS INCIDENT AND THE FINDINGS. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
ADDITIONAL INFORMATION WAS PROVIDED.
IT WAS REPORTED WHILE USING BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT 20 GA 1.25 IN THE CATHETER WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: NEXIVA FEELS DRY WHEN MOVING IT TO TAKE OFF THE CATHETER BEFORE PUNCTING.
IT WAS REPORTED WHILE USING BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT 20 GA 1.25 IN THE CATHETER WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: NEXIVA FEELS DRY WHEN MOVING IT TO TAKE OFF THE CATHETER BEFORE PUNCTING.
IT WAS REPORTED WHILE USING BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT 20 GA 1.25 IN THE NEEDLE DISENGAGEMENT WAS DIFFICULT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: NEXIVA FEELS DRY WHEN MOVING IT TO TAKE OFF THE CATHETER BEFORE PUNCTURING. ADDITIONAL INFORMATION RECEIVED ON 08.JUN.2023: HOW MANY UNITS OF THE PRODUCT PRESENTED THE REPORTED DEVIATION? WAS THE REPORTED INCIDENT NOTED BEFORE, DURING, OR AFTER USE ON THE PATIENT? ONLY 1 UNIT REPORTED THIS FAILURE TO ME, THIS INCIDENT WAS DURING THE PROCEDURE BEFORE PUNCTURING THE PATIENT. WITH RESPECT TO THE WORD ¿DRY¿, DO YOU MEAN THAT THE METAL PART OF THE PRODUCT SEEMS TO BE WITHOUT LUBRICATION/FRICTION/DIFFICULT TO MOVE? IT WAS WITHOUT LUBRICATION AND WHEN REMOVING AND INSERTING THE BEZEL IT MADE THAT METAL RUBBING SOUND. IS THE DEFECT IDENTIFIED DURING THE ROTATION OF THE METAL PART SO THAT IT DETACHES FROM THE CATHETER, BEFORE THE PATIENT IS PUNCTURED? (IF NOT, CLARIFY WHICH PART OF THE PROCESS YOU ARE REFERRING TO). THE DEFECT IS THAT IT WAS VERY DIFFICULT TO DETACH THE METAL PART. TOO MUCH FORCE HAD TO BE APPLIED TO BE ABLE TO EXTRACT THE METAL PART, DETECTING THE FAULT AND IT WAS NOT USED ON THE PATIENT. IS THE SAMPLE RELATED TO THE INCIDENT AVAILABLE FOR ANALYSIS? THE MATERIAL WAS DELIVERED TO THE HOSPITAL'S SUPPLY WAREHOUSE. A VIDEO AND PHOTO OF THE PRODUCT PACKAGING WAS SENT TO THE LADY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 814924 | BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT 20 GA 1.25 IN | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | 383517 | 2173237 | 30382903835172 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |