BD VENLON PRO SAFETY CATHETER
Report
- Report Number
- 2243072-2021-02957
- Event Type
- Malfunction
- Date Received
- December 21, 2021
- Date of Event
- November 23, 2021
- Report Date
- May 30, 2024
- Manufacturer
- BECTON DICKINSON
- Product Code
- FOZ
- PMA / PMN Number
- UNKNOWN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING INFORMATION HAS BEEN CORRECTED: H.6. IMDRF ANNEX A CODE: A041001 - MATERIAL PUNCTURE / HOLE (1504).
UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.
FOLLOW UP MDR FOR DEVICE EVALUATION. NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED FOR THE REPORTED ISSUE OF ¿IN CONNECTION WITH PAT GETTING A PVK BEFORE THE X-RAY. INSERT PVK IN A FINE VESSEL, GET BACKFLOW AND MUST INSERT PVK FURTHER BUT IT STOPS, MUST BACK OUT PVKN TO ADJUST THE DIRECTION BUT IT GETS STUCK / RECEIVES. DECIDE TO PULL OUT THE PVKN SO AS NOT TO DAMAGE THE VESSEL. WHEN I PULL OUT THE PVK, I FEEL HOW IT STICKS ALL THE WAY OUT AND IT TURNS OUT THAT THE MANDREL HAS PASSED THROUGH THE PLASTIC HOSE ABOUT 3 MM BELOW THE END OF THE HOSE. THE ABOVE IS AN AHA REGARDING PVK FROM BD. IT IS NOW THE 3RD PVK THAT BROKE IN CONNECTION WITH THE INTRODUCTION. AT THE FIRST INCIDENT, WE DISCARDED THEM WITH THE SAME BATCH, BUT NOW WE REMOVE THEM ALL WITHOUT PROTECTION¿ WITH LOT NUMBER UNKNOWN REGARDING ITEM # (B)(4), SO RETENTION SAMPLES WERE USED FOR THE INVESTIGATION. THE NUMBER OF COMPLAINTS AND THE TREND OF THE COMPLAINTS EVALUATION COULD NOT BE DETERMINED AS THE LOT NUMBER WAS NOT REPORTED BY THE CUSTOMER. THE DHR OF MATERIAL NUMBER 393204 AND LOT NUMBER UNKNOWN COULD NOT HELP THE INVESTIGATING TEAM TO DO THE DHR REVIEW. THE INVESTIGATION TEAM COULD NOT ALSO USE RETENTION SAMPLES OF MATERIAL CODE 393204 AS THE LOT NUMBER IS UNKNOWN FOR INVESTIGATING THE REPORTED DEFECT OF DAMAGED IVC PRODUCT. AS NO PHOTOGRAPH OR SAMPLES AND NO LOT NUMBER WERE RECEIVED FROM THE CUSTOMER FOR THE REPORTED DEFECT OF PRODUCT GIVING RESISTANCE IN INSERTION, THE DEFECT IS NOT CONFIRMED. AS NO PHOTOGRAPH OR SAMPLES AND NO LOT NUMBER WERE RECEIVED FROM THE CUSTOMER FOR THE REPORTED DEFECT OF PRODUCT GIVING RESISTANCE IN INSERTION, THE DEFECT IS NOT CONFIRMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.
UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.
IT WAS REPORTED THAT THE BD VENLON PRO SAFETY CATHETER EXPERIENCED THE NEEDLE PIERCING THROUGH THE CATHETER DURING INTRODUCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INSERTED PVK IN A FINE VESSEL, GET BACKFLOW AND HAD TO INSERT PVK FURTHER BUT IT STOPPED, HAD TO BACK OUT PVKN TO ADJUST THE DIRECTION BUT IT GOT STUCK / RECEIVED. DECIDED TO PULL OUT THE PVKN SO AS NOT TO DAMAGE THE VESSEL. WHEN I PULLED OUT THE PVK, I FELT HOW IT STUCK ALL THE WAY OUT AND IT TURNED OUT THAT THE MANDREL PASSED THROUGH THE PLASTIC HOSE ABOUT 3 MM BELOW THE END OF THE HOSE. 5552113 PVK VENFLON PRO 1,1X32MM ROSA?
IT WAS REPORTED THAT THE BD VENLON PRO SAFETY CATHETER EXPERIENCED THE NEEDLE PIERCING THROUGH THE CATHETER DURING INTRODUCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INSERTED PVK IN A FINE VESSEL, GET BACKFLOW AND HAD TO INSERT PVK FURTHER BUT IT STOPPED, HAD TO BACK OUT PVKN TO ADJUST THE DIRECTION BUT IT GOT STUCK / RECEIVED. DECIDED TO PULL OUT THE PVKN SO AS NOT TO DAMAGE THE VESSEL. WHEN I PULLED OUT THE PVK, I FELT HOW IT STUCK ALL THE WAY OUT AND IT TURNED OUT THAT THE MANDREL PASSED THROUGH THE PLASTIC HOSE ABOUT 3 MM BELOW THE END OF THE HOSE.
IT WAS REPORTED THAT THE BD VENLON PRO SAFETY CATHETER EXPERIENCED THE NEEDLE PIERCING THROUGH THE CATHETER DURING INTRODUCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INSERTED PVK IN A FINE VESSEL, GET BACKFLOW AND HAD TO INSERT PVK FURTHER BUT IT STOPPED, HAD TO BACK OUT PVKN TO ADJUST THE DIRECTION BUT IT GOT STUCK / RECEIVED. DECIDED TO PULL OUT THE PVKN SO AS NOT TO DAMAGE THE VESSEL. WHEN I PULLED OUT THE PVK, I FELT HOW IT STUCK ALL THE WAY OUT AND IT TURNED OUT THAT THE MANDREL PASSED THROUGH THE PLASTIC HOSE ABOUT 3 MM BELOW THE END OF THE HOSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1952569 | BD VENLON PRO SAFETY CATHETER | INTERVASCULAR CATHETER | FOZ | BECTON DICKINSON | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |