VENFLON PRO 0.9MM X 25MM
Report
- Report Number
- 2243072-2021-01545
- Event Type
- Injury
- Date Received
- May 26, 2021
- Date of Event
- April 12, 2021
- Report Date
- September 10, 2021
- Product Code
- FOZ
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED FOR THE REPORTED ISSUE OF CATHETER BREAKING AND GETTING LEFT BEHIND INTO THE PATIENTS¿ VEINS¿ WITH LOT NUMBER 182415 REGARDING ITEM # 393202, SO RETENTION SAMPLES WERE USED FOR THE INVESTIGATION. THE DHR OF LOT NUMBER 393202 AND BATCH NUMBER OF 182415 WAS REVIEWED AND NO QUALITY NOTIFICATION WAS FOUND ON THIS LOT NUMBER. THE INVESTIGATION TEAM HAVE RECEIVED CONFIRMATION THAT THE CUSTOMER IS REFERRING TO PTFE TUBE AND NOT THE SILICONE TUBE THE RETENTION SAMPLES OF 0182415 WERE RETESTED FOR FOLLOWING INVESTIGATION. SIMULATION OF DAMAGE PRODUCT WITH VARIOUS MEDIA: BY HAND. BY EQUIPMENT. BY SHARP ACCESSORIES (KNIFE / BLADE). THE INVESTIGATION TEAM HAS CARRIED OUT THE SIMULATION OF THE COMPLAINT ON THE TEN RETENTION SAMPLES OF PRODUCT MATERIAL CODE 393202 AND LOT NUMBER 0182415. BASED ON THE SIMULATION CARRIED OUT ON THE VENFLON PRO 18GA RETENTION SAMPLE THE DEFECT COULD NOT BE CONFIRMED. THE PROBABLE ROOT CAUSE OF THE CATHETER BREAKING AND GETTING LEFT BEHIND INTO THE PATIENTS¿ VEINS COULD BE: THERE IS NO ISSUE FOUND RELATED TO PTFE TUBE IN PLANT WITH RESPECT TO PROCESS. THE DEFECT SIMULATED BY BLADE OR KNIFE CUTTING WHERE IT CUTS INTO TWO PIECES SUGGESTS THAT THE CATHETER WAS ACCIDENTLY CUT BY THE BLADE OR KNIFE WHILE DISCONTINUING THE PVK LINE. SINCE THERE IS NO SAMPLE OR PHOTOGRAPH THE DEFECT CANNOT BE CONFIRMED. THE DEFECT IS UNCONFIRMED AS THERE IS NO SAMPLE AVAILABLE TO CONFIRM THE REPORTED DEFECT.
H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED FOR THE REPORTED ISSUE OF ¿WHEN DISCONTINUING PVK IN THE RIGHT ELBOW BEND, IT IS DISCOVERED THAT THE SMALL SILICONE TUBE HAS BROKEN, AND THERE IS THUS A TUBE OF 2-3 CM LEFT IN THE PATIENT'S ARM¿, WITH REPORTED LOT #0182415 REGARDING ITEM #393202, SO THE INVESTIGATING TEAM HAS USED THE RETENTION SAMPLES OF LOT NUMBER 0182415 FOR INVESTIGATING THE REPORTED DEFECT. THE DHR OF CAT# 393202 AND BATCH NUMBER OF 0182415 WAS REVIEWED AND NO QUALITY NOTIFICATION WAS FOUND ON THIS LOT NUMBER. THIS IS RELATED TO VENFLON PRO LEAKAGE. BD WAS ABLE TO DUPLICATE OR CONFIRM THE INDICATED FAILURE AS PRODUCT IS ALREADY RECALLED AND R&D TEAM IS DOING CAPA # 2807642 FOR THE SAME. H3 OTHER TEXT : SEE H.10.
IT WAS REPORTED THAT VENFLON PRO 0.9MM X 25MM WAS BROKEN AND LEFT A TUBE IN THE PATIENT'S ARM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN DISCONTINUING PVK IN THE RIGHT ELBOW BEND, IT IS DISCOVERED THAT THE SMALL SILICONE TUBE HAS BROKEN, AND THERE IS THUS A TUBE OF 2-3 CM LEFT IN THE PATIENT'S ARM. THE CONSEQUENCE FOR THE PATIENT IS THAT HE UNDERWENT GENERAL ANESTHESIA, AS IT IS ASSESSED THAT HE CANNOT CONTROL THE SEIZURES AND THUS DOES NOT HAVE SEIZURES DURING THE PROCEDURE UNDER LOCAL ANESTHESIA. THE HOSE PIECE SHOULD BE REMOVED AS THE PATIENT RISKS THE PIECE WANDERING AROUND THE BODY. THEY REMOVED IT AND THE PATIENT WAS FINE AFTERWARDS. THEY ARE NOT 100% SURE OF LOT, BUT ALL THE OTHER REF (B)(4) THERE WHERE IN THE WARD WAS THIS LOT. THE CASE IS NAMED "UTILSIGTET HÆNDELSE" CHILD, AND THE REASON FOR TAKING THE CHILD IN GENERAL ANESTHESIA WAS THAT THE PATIENT HAS A DISEASE IN WHICH HE OFTEN CRAMPS, SO THAT THE PATIENT COULD LIE STILL IT WAS NECESSARY TO PUT THE PATIENT IN GENERAL ANESTHESIA.
IT WAS REPORTED THAT VENFLON PRO 0.9MM X 25MM WAS BROKEN AND LEFT A TUBE IN THE PATIENT'S ARM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN DISCONTINUING PVK IN THE RIGHT ELBOW BEND, IT IS DISCOVERED THAT THE SMALL SILICONE TUBE HAS BROKEN, AND THERE IS THUS A TUBE OF 2-3 CM LEFT IN THE PATIENT'S ARM. THE CONSEQUENCE FOR THE PATIENT IS THAT HE UNDERWENT GENERAL ANESTHESIA, AS IT IS ASSESSED THAT HE CANNOT CONTROL THE SEIZURES AND THUS DOES NOT HAVE SEIZURES DURING THE PROCEDURE UNDER LOCAL ANESTHESIA. THE HOSE PIECE SHOULD BE REMOVED AS THE PATIENT RISKS THE PIECE WANDERING AROUND THE BODY. THEY REMOVED IT AND THE PATIENT WAS FINE AFTERWARDS. THEY ARE NOT 100% SURE OF LOT, BUT ALL THE OTHER REF 393202 THERE WHERE IN THE WARD WAS THIS LOT. THE CASE IS NAMED "UTILSIGTET HÆNDELSE" CHILD, AND THE REASON FOR TAKING THE CHILD IN GENERAL ANESTHESIA WAS THAT THE PATIENT HAS A DISEASE IN WHICH HE OFTEN CRAMPS, SO THAT THE PATIENT COULD LIE STILL IT WAS NECESSARY TO PUT THE PATIENT IN GENERAL ANESTHESIA.
THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS NOT REGISTERED WITH THE FDA. THEREFORE, (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT VENFLON PRO 0.9MM X 25MM WAS BROKEN AND LEFT A TUBE IN THE PATIENT'S ARM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN DISCONTINUING PVK IN THE RIGHT ELBOW BEND, IT IS DISCOVERED THAT THE SMALL SILICONE TUBE HAS BROKEN, AND THERE IS THUS A TUBE OF 2-3 CM LEFT IN THE PATIENT'S ARM. THE CONSEQUENCE FOR THE PATIENT IS THAT HE UNDERWENT GENERAL ANESTHESIA, AS IT IS ASSESSED THAT HE CANNOT CONTROL THE SEIZURES AND THUS DOES NOT HAVE SEIZURES DURING THE PROCEDURE UNDER LOCAL ANESTHESIA. THE HOSE PIECE SHOULD BE REMOVED AS THE PATIENT RISKS THE PIECE WANDERING AROUND THE BODY. THEY REMOVED IT AND THE PATIENT WAS FINE AFTERWARDS. THEY ARE NOT 100% SURE OF LOT, BUT ALL THE OTHER REF 393202 THERE WHERE IN THE WARD WAS THIS LOT. THE CASE IS NAMED "UTILSIGTET H¿NDELSE" CHILD, AND THE REASON FOR TAKING THE CHILD IN GENERAL ANESTHESIA WAS THAT THE PATIENT HAS A DISEASE IN WHICH HE OFTEN CRAMPS, SO THAT THE PATIENT COULD LIE STILL IT WAS NECESSARY TO PUT THE PATIENT IN GENERAL ANESTHESIA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 786788 | VENFLON PRO 0.9MM X 25MM | CATHETER | FOZ | 0182415 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |