BD VENFLON¿ PRO SAFETY
Report
- Report Number
- 8041187-2023-00511
- Event Type
- Injury
- Date Received
- September 28, 2023
- Date of Event
- August 24, 2023
- Report Date
- February 6, 2024
- Manufacturer
- BECTON DICKINSON MEDICAL (SINGAPORE)
- Product Code
- FOZ
- UDI-DI
- 00382903932269
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.6. INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE 2 PHOTOS SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF CATHETER BROKEN/ SEPARATED AFTER PLACEMENT WAS CONFIRMED UPON INSPECTION OF THE PHOTOS. HOWEVER, BD CANNOT CONFIRM THE CAUSE OF THE FAILURE TO OUR MANUFACTURING PROCESS SINCE NO SAMPLE WAS RETURNED FOR EVALUATION. EXAMINATION OF THE ACTUAL PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE OF THE REPORTED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
INVESTIGATION SUMMARY COMPLETED IN FIRST FOLLOW UP, THIS SUPPLEMENTAL WAS FILED FOR ANNEX A CODE UPDATE. SEE NARRATIVE BELOW.
THE MANUFACTURING PROCESS HAS BEEN REVIEWED AND THERE ARE NO SHARP EDGES THAT COULD POSSIBLY COME INTO CONTACT WITH THE CATHETER TO CAUSE THE CUT. THERE IS AN AUTOMATED VISION INSPECTION SYSTEM THAT CAN DETECT AND REJECT PRODUCT NOT MEETING THE LIE DISTANCE REQUIREMENT. IF THE CATHETER IS BROKEN IN THE MANUFACTURING PROCESS, THE DEFECTIVE PART WOULD BE REJECTED BY THE AUTOMATED VISION INSPECTION SYSTEM AS THE PRODUCT WILL NOT HAVE ANY LIE DISTANCE. IT WOULD ALSO NOT BE POSSIBLE TO USE THE PRODUCT IF THE CATHETER IS BROKEN BEFORE USE. BASED ON THE RETURNED PHOTO, THE PROBABLE ROOT CAUSE FOR THE BROKEN CATHETER COULD BE DUE TO CATHETER BEING CUT BY SHARP OBJECTS SUCH AS SCISSORS DURING PRODUCT INSERTION, DRESSING, OR REMOVAL FROM VEIN. IT WAS STATED IN THE INSTRUCTION FOR USE ¿DO NOT USE SCISSORS AT OR CLOSE TO THE INSERTION SITE.¿. HOWEVER, AS IT IS IMPOSSIBLE TO CONFIRM HOW THE PRODUCT HAS BEEN USED, THE ROOT CAUSE CANNOT BE DETERMINED. AS NO SIMILAR QUALITY NOTIFICATION WAS RAISED FOR THE REPORTED DEFECT IN THE PAST 12 MONTHS. COMPLAINT TREND WOULD BE MONITORED. H3 OTHER TEXT : SEE H10 MANUFACTURE NARRATIVE.
THE MANUFACTURING PROCESS HAS BEEN REVIEWED AND THERE ARE NO SHARP EDGES THAT COULD POSSIBLY COME INTO CONTACT WITH THE CATHETER TO CAUSE THE CUT. THERE IS AN AUTOMATED VISION INSPECTION SYSTEM THAT CAN DETECT AND REJECT PRODUCT NOT MEETING THE LIE DISTANCE REQUIREMENT. IF THE CANNULA PIERCE THROUGH THE CATHETER OR CATHETER BROKEN IN THE MANUFACTURING PROCESS, THE DEFECTIVE PART WOULD BE REJECTED BY THE AUTOMATED VISION INSPECTION SYSTEM AS THE PRODUCT WILL NOT HAVE ANY LIE DISTANCE. IT WOULD ALSO NOT BE POSSIBLE TO USE THE PRODUCT IF THE CATHETER IS BROKEN OR CANNULA PIERCED THROUGH THE CATHETER. A SIMULATED SAMPLE OF CANNULA PIERCING THROUGH CATHETER, WHICH IS TALLY WITH THE V-CUT ON THE RETURNED SAMPLE. BASED ON THE RETURNED SAMPLE, THE PROBABLE ROOT CAUSE FOR THE REPORTED DEFECT COULD BE DUE TO USER HAD PARTIALLY WITHDRAWN THE NEEDLE FROM THE CATHETER AND REINSERTING THE NEEDLE INTO THE CATHETER, THE NEEDLE PIERCE THROUGH THE CATHETER AND DAMAGE THE CATHETER, AND THE CATHETER BROKEN DURING THE REMOVAL PROCESS EVENTUALLY. PRODUCT IFU IS CLEARLY STATED THAT NEVER REINSERT THE NEEDLE INTO THE CATHETER. HOWEVER, AS IT IS NOT POSSIBLE TO CONFIRM HOW THE PRODUCT HAS BEEN USED, THE ROOT CAUSE CANNOT BE DETERMINED. A REVIEW OF PAST 12 MONTHS QUALITY NOTIFICATION WAS PERFORMED. NO SIMILAR QUALITY NOTIFICATION WAS RAISED FOR THE REPORTED DEFECT. COMPLAINT TREND WOULD BE MONITORED.
D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT THE BD VENFLON¿ PRO SAFETY CATHETER SEPARATED FROM THE HUB. THE FOLLOWING WAS TRASLATED FROM SWEDISH TO ENGLISH: IN CONNECTION WITH GOING HOME, PVK MUST BE REMOVED FROM THE LEFT ARM CREASE. CARRY OUT ACTION AS REQUESTED BY SSK. WHEN PVK IS PULLED OUT OF THE ARM, YOU HEAR A "CLICKING" SOUND AND THEN SEE THAT THE PLASTIC CATHETER ON THE PVK DOES NOT FOLLOW OUT OF THE ARM. SEE THAT ONLY A SMALL PART OF THE PLASTIC CATHETER REMAINS ON THE PVK ITSELF. CAN'T SEE THAT THE REST OF THE PLASTIC CATHETER IS IN PLACE REMAIN IN THE BLOOD VESSEL. IF BLOOD COMES FROM THE INJECTION SITE, APPLY THE USUAL DRESSING. PVK WAS ADMITTED ON 22/8 AT THE EMERGENCY DEPARTMENT. CONTACT RESPONSIBLE SSK AND DOCTOR. DOCTORS COME TO THE SCENE AND PALPATE THE ARM AT THE INSERTION SITE AND THEN DO BEDSIDE ULTRASOUND. THEN DECIDES TO X-RAY THE ARM AT THE ANGIOLAB, WHICH ALSO DOES NOT SHOW IF AND WHERE THE PLASTIC CATHETER REMAINS. REFERRAL IS WRITTEN FOR ULTRASOUND WHICH IS CARRIED OUT ON X-RAY AFTERWARDS. THE CATHETER IS NOT FOUND. WHAT WAS THE CONSEQUENCE FOR THE PATIENT/USER? OTHER THE PATIENT IS ASKED TO PAY ATTENTION TO SYMPTOMS.
NO ADDITIONAL INFORMATION RECEIVED. IN CONNECTION WITH GOING HOME, PVK MUST BE REMOVED FROM THE LEFT ARM CREASE. CARRY OUT ACTION AS REQUESTED BY SSK. WHEN PVK IS PULLED OUT OF THE ARM, YOU HEAR A "CLICKING" SOUND AND THEN SEE THAT THE PLASTIC CATHETER ON THE PVK DOES NOT FOLLOW OUT OF THE ARM. SEE THAT ONLY A SMALL PART OF THE PLASTIC CATHETER REMAINS ON THE PVK ITSELF. CAN'T SEE THAT THE REST OF THE PLASTIC CATHETER IS IN PLACE REMAIN IN THE BLOOD VESSEL. IF BLOOD COMES FROM THE INJECTION SITE, APPLY THE USUAL DRESSING. PVK WAS ADMITTED ON 22/8 AT THE EMERGENCY DEPARTMENT. CONTACT RESPONSIBLE SSK AND DOCTOR. DOCTORS COME TO THE SCENE AND PALPATE THE ARM AT THE INSERTION SITE AND THEN DO BEDSIDE ULTRASOUND. THEN DECIDES TO X-RAY THE ARM AT THE ANGIOLAB, WHICH ALSO DOES NOT SHOW IF AND WHERE THE PLASTIC CATHETER REMAINS. REFERRAL IS WRITTEN FOR ULTRASOUND WHICH IS CARRIED OUT ON X-RAY AFTERWARDS. THE CATHETER IS NOT FOUND. UNFORTUNATELY, THE LOT/BATCH NUMBER IS MISSING, IT HAS NOT BEEN POSSIBLE TO GET HOLD OF IT. WHAT WAS THE CONSEQUENCE FOR THE PATIENT/USER? OTHER BRIEFLY DESCRIBE WHAT IS MEANT BY OTHER (MAX. 50 CHARACTERS) THE PATIENT IS ASKED TO PAY ATTENTION TO SYMPTOMS.
NO ADDITIONAL INFORMATION RECEIVED. IN CONNECTION WITH GOING HOME, PVK MUST BE REMOVED FROM THE LEFT ARM CREASE. CARRY OUT ACTION AS REQUESTED BY SSK. WHEN PVK IS PULLED OUT OF THE ARM, YOU HEAR A "CLICKING" SOUND AND THEN SEE THAT THE PLASTIC CATHETER ON THE PVK DOES NOT FOLLOW OUT OF THE ARM. SEE THAT ONLY A SMALL PART OF THE PLASTIC CATHETER REMAINS ON THE PVK ITSELF. CAN'T SEE THAT THE REST OF THE PLASTIC CATHETER IS IN PLACE REMAIN IN THE BLOOD VESSEL. IF BLOOD COMES FROM THE INJECTION SITE, APPLY THE USUAL DRESSING. PVK WAS ADMITTED ON 22/8 AT THE EMERGENCY DEPARTMENT. CONTACT RESPONSIBLE SSK AND DOCTOR. DOCTORS COME TO THE SCENE AND PALPATE THE ARM AT THE INSERTION SITE AND THEN DO BEDSIDE ULTRASOUND. THEN DECIDES TO X-RAY THE ARM AT THE ANGIOLAB, WHICH ALSO DOES NOT SHOW IF AND WHERE THE PLASTIC CATHETER REMAINS. REFERRAL IS WRITTEN FOR ULTRASOUND WHICH IS CARRIED OUT ON X-RAY AFTERWARDS. THE CATHETER IS NOT FOUND. UNFORTUNATELY, THE LOT/BATCH NUMBER IS MISSING, IT HAS NOT BEEN POSSIBLE TO GET HOLD OF IT. WHAT WAS THE CONSEQUENCE FOR THE PATIENT/USER? OTHER BRIEFLY DESCRIBE WHAT IS MEANT BY OTHER (MAX. 50 CHARACTERS) THE PATIENT IS ASKED TO PAY ATTENTION TO SYMPTOMS.
IN CONNECTION WITH GOING HOME, PVK MUST BE REMOVED FROM THE LEFT ARM CREASE. CARRY OUT ACTION AS REQUESTED BY SSK. WHEN PVK IS PULLED OUT OF THE ARM, YOU HEAR A "CLICKING" SOUND AND THEN SEE THAT THE PLASTIC CATHETER ON THE PVK DOES NOT FOLLOW OUT OF THE ARM. SEE THAT ONLY A SMALL PART OF THE PLASTIC CATHETER REMAINS ON THE PVK ITSELF. CAN'T SEE THAT THE REST OF THE PLASTIC CATHETER IS IN PLACE REMAIN IN THE BLOOD VESSEL. IF BLOOD COMES FROM THE INJECTION SITE, APPLY THE USUAL DRESSING. PVK WAS ADMITTED ON (B)(6) AT THE EMERGENCY DEPARTMENT. CONTACT RESPONSIBLE SSK AND DOCTOR. DOCTORS COME TO THE SCENE AND PALPATE THE ARM AT THE INSERTION SITE AND THEN DO BEDSIDE ULTRASOUND. THEN DECIDES TO X-RAY THE ARM AT THE ANGIOLAB, WHICH ALSO DOES NOT SHOW IF AND WHERE THE PLASTIC CATHETER REMAINS. REFERRAL IS WRITTEN FOR ULTRASOUND WHICH IS CARRIED OUT ON X-RAY AFTERWARDS. THE CATHETER IS NOT FOUND. UNFORTUNATELY, THE LOT/BATCH NUMBER IS MISSING, IT HAS NOT BEEN POSSIBLE TO GET HOLD OF IT. WHAT WAS THE CONSEQUENCE FOR THE PATIENT/USER? OTHER. BRIEFLY DESCRIBE WHAT IS MEANT BY OTHER (MAX. 50 CHARACTERS): THE PATIENT IS ASKED TO PAY ATTENTION TO SYMPTOMS.
IT WAS REPORTED THAT THE BD VENFLON¿ PRO SAFETY CATHETER SEPARATED FROM THE HUB. THE FOLLOWING WAS TRASLATED FROM SWEDISH TO ENGLISH: IN CONNECTION WITH GOING HOME, PVK MUST BE REMOVED FROM THE LEFT ARM CREASE. CARRY OUT ACTION AS REQUESTED BY (B)(6). WHEN PVK IS PULLED OUT OF THE ARM, YOU HEAR A "CLICKING" SOUND AND THEN SEE THAT THE PLASTIC CATHETER ON THE PVK DOES NOT FOLLOW OUT OF THE ARM. SEE THAT ONLY A SMALL PART OF THE PLASTIC CATHETER REMAINS ON THE PVK ITSELF. CAN'T SEE THAT THE REST OF THE PLASTIC CATHETER IS IN PLACE REMAIN IN THE BLOOD VESSEL. IF BLOOD COMES FROM THE INJECTION SITE, APPLY THE USUAL DRESSING. (B)(6) WAS ADMITTED ON 22/8 AT THE EMERGENCY DEPARTMENT. CONTACT RESPONSIBLE (B)(6) AND DOCTOR. DOCTORS COME TO THE SCENE AND PALPATE THE ARM AT THE INSERTION SITE AND THEN DO BEDSIDE ULTRASOUND. THEN DECIDES TO X-RAY THE ARM AT THE ANGIOLAB, WHICH ALSO DOES NOT SHOW IF AND WHERE THE PLASTIC CATHETER REMAINS. REFERRAL IS WRITTEN FOR ULTRASOUND WHICH IS CARRIED OUT ON X-RAY AFTERWARDS. THE CATHETER IS NOT FOUND. WHAT WAS THE CONSEQUENCE FOR THE PATIENT/USER? OTHER, THE PATIENT IS ASKED TO PAY ATTENTION TO SYMPTOMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1835629 | BD VENFLON¿ PRO SAFETY | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON MEDICAL (SINGAPORE) | UNKNOWN | 00382903932269 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |