BD VENFLON¿ IV CATHETERS
Report
- Report Number
- 2243072-2021-02840
- Event Type
- Injury
- Date Received
- December 1, 2021
- Date of Event
- November 2, 2021
- Report Date
- December 2, 2021
- Manufacturer
- BECTON DICKINSON
- Product Code
- FOZ
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
FOR OEM MANUFACTURING SITES: IN THIS MDR, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED IN SECTIONS AS (B)(4) IS AN OEM MANUFACTURING SITE. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
H6: INVESTIGATION SUMMARY NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED FOR THE REPORTED ISSUE OF ¿BLUNT NEEDLE¿ ¿ WITH LOT NUMBER 1033876 REGARDING ITEM # 391453, SO RETENTION SAMPLES WERE USED FOR THE INVESTIGATION. THE DHR OF MATERIAL NUMBER 391453 AND LOT NUMBER 1033876 WAS CHECKED AND NO QUALITY NOTIFICATIONS WERE RECORDED ON THIS LOT. THE DHR AND RETENTION SAMPLES WERE USED FOR INVESTIGATION THE DEFECT OF DULL/BLUNT NEEDLE IN MATERIAL CODE 391453 AND LOT NUMBER 1033876. THE DHR WAS REVIEWED FOR THE ROUTINE NEEDLE PENETRATION TEST AND AFTER STERILE TESTING AND THE RESULTS WERE FOUND TO BE WITHIN SPECIFICATION. THE INVESTIGATING TEAM COULD NOT INVESTIGATE FURTHER AS THE ORIGINAL SAMPLE IS NOT AVAILABLE FOR INVESTIGATION. THE RETENTION SAMPLES WERE TESTED FOR THE NEEDLE PENETRATION TESTS AND NONE OF THE TEN RETENTION SAMPLES OF LOT NUMBER 1033897 SHOWED ANY VARIATION IN THE NEEDLE PENETRATION TESTS, CONFIRMING THAT THERE IS NO DULL/BLUNT NEEDLE IN THEM. THE DEFECT COULD NOT BE CONFIRMED. SINCE NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED FOR THE REPORTED ISSUE OF ¿INFLAMMATORY REACTIONS¿ WITH LOT NUMBER 1033876 REGARDING ITEM # 391453 THE COMPLAINT COULD NOT BE CONFIRMED, AND THE ROOT CAUSE IS UNDETERMINED. H3 OTHER TEXT : SEE H10.
IT WAS REPORTED THAT THERE WAS INFLAMMATORY REACTION WITH PATIENTS WHEN USING BD VENFLON¿ IV CATHETERS. WITH 2 PATIENTS THE REACTION WAS REQUIRED SURGICAL CONSULTATION AND ANTIBIOTIC THERAPY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM POLISH TO ENGLISH: I WOULD LIKE TO INFORM YOU THAT WHEN USING BD VENFLON 18 GA 1.2 X 45 MM, SERIES NUMBER 1033876, WE OBSERVE A LARGE NUMBER OF INFLAMMATORY REACTIONS AMONG PATIENTS. REACTIONS OCCUR BOTH IN THE ELDERLY AND IN YOUNG PATIENTS, WITH VARYING DEGREES OF SEVERITY OF SYMPTOMS, SOMETIMES IN THE FIRST 24 HOURS AFTER INSERTION OF THE PUNCTURE. IT HAPPENED TWICE THAT THE INFLAMMATORY REACTION WAS SO SEVERE THAT IT REQUIRED A SURGICAL CONSULTATION AND THE INTRODUCTION OF ANTIBIOTIC THERAPY.
IT WAS REPORTED THAT THERE WAS INFLAMMATORY REACTION WITH PATIENTS WHEN USING BD VENFLON¿ IV CATHETERS. WITH 2 PATIENTS THE REACTION WAS REQUIRED SURGICAL CONSULTATION AND ANTIBIOTIC THERAPY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM POLISH TO ENGLISH: I WOULD LIKE TO INFORM YOU THAT WHEN USING BD VENFLON 18 GA 1.2 X 45 MM, SERIES NUMBER 1033876, WE OBSERVE A LARGE NUMBER OF INFLAMMATORY REACTIONS AMONG PATIENTS. REACTIONS OCCUR BOTH IN THE ELDERLY AND IN YOUNG PATIENTS, WITH VARYING DEGREES OF SEVERITY OF SYMPTOMS, SOMETIMES IN THE FIRST 24 HOURS AFTER INSERTION OF THE PUNCTURE. IT HAPPENED TWICE THAT THE INFLAMMATORY REACTION WAS SO SEVERE THAT IT REQUIRED A SURGICAL CONSULTATION AND THE INTRODUCTION OF ANTIBIOTIC THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1805015 | BD VENFLON¿ IV CATHETERS | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON | 1033876 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |