BD ARTERIAL CANNULA 20G/45MM
Report
- Report Number
- 2243072-2023-02240
- Event Type
- Injury
- Date Received
- December 22, 2023
- Date of Event
- November 29, 2023
- Report Date
- April 15, 2024
- Manufacturer
- BECTON DICKINSON
- Product Code
- FOZ
- UDI-DI
- 00382906822451
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
BASED ON THE DHR REVIEW, THERE IS AN OUTGOING INSPECTION TO INSPECT FOR PRODUCT DAMAGED DURING THE IN-PROCESS INSPECTION, NO CATHETER TUBING DEFECT QN BEING RAISE FOR THE ASSEMBLY NEEDLE (AN) BATCH USED TO PRODUCE THIS COMPLAINT BATCH. 7 PHOTOS WERE RECEIVED FOR THIS COMPLAINT. BROKEN CATHETER WAS OBSERVED IN THE PHOTOS RECEIVED. NO SAMPLE WAS RECEIVED. IF THERE WAS A SAMPLE RECEIVED, THE BROKEN CATHETER CAN BE INVESTIGATED TO DETERMINE ITS CAUSE, THE COMPLAINT WILL BE RE-OPEN WHEN THERE IS A SAMPLE RECEIVED. THE COMPLAINT TREND WILL BE MONITORED.
BASED ON THE DHR REVIEW, THERE IS AN OUTGOING INSPECTION TO INSPECT FOR PRODUCT DAMAGED DURING THE IN-PROCESS INSPECTION, NO CATHETER TUBING DEFECT QN BEING RAISE FOR THE ASSEMBLY NEEDLE (AN) BATCH USED TO PRODUCE THIS COMPLAINT BATCH. 7 PHOTOS WERE RECEIVED FOR THIS COMPLAINT. BROKEN CATHETER WAS OBSERVED IN THE PHOTOS RECEIVED. 1 SAMPLE WAS RECEIVED. BROKEN CATHETER WAS OBSERVED ON THE SAMPLE. ONLY THE HOUSING END HAS BEEN RETURNED, THE CATHETER TUBING END IS NOT RETURNED. THE BROKEN OFF AREA IS APPROXIMATELY 6MM FROM NOSE AREA OF THE HOUSING. THE PART OFF AREA OF THE BROKEN OFF AREA WAS OBSERVED TO HAVE A CLEAN CUT. ARTERIAL CANNULA TUBE DRAW MACHINE THE MACHINE PARTS THAT CONTACT THE CATHETER TUBING WERE THE MACHINE GRIPPERS. HOWEVER, THE MACHINE GRIPPERS HAVE ROUND FLAT SURFACE WITH NO SHARP EDGES THAT COULD CAUSE PART-OFF IN THE CATHETER TUBING. ARTERIAL CANNULA ASSEMBLY MACHINE THERE IS AN AUTOMATED VISION INSPECTION MACHINE AT THE ARTERIAL CANNULA ASSEMBLY MACHINE, AND IT WILL AUTO REJECT ANY PARTS NOT MEETING THE LIE DISTANCE REQUIREMENT. IF THE CATHETER TUBING IS BROKEN, ITS LIE DISTANCE WOULD MOST LIKELY HAVE FAILED AND WILL AUTOMATICALLY BE REJECTED BY THE LINE. A SIMULATION WAS CARRIED OUT BY USING SCISSORS TO PART-OFF A CATHETER. THE PART-OFF SURFACE IS THEN OBSERVED. A CLEAN CUT IS OBSERVED ON THE PART-OFF SURFACE. BASED ON THE BROKEN CATHETER COULD HAVE BEEN CAUSED BY A SHARP OBJECT SUCH AS A SCISSORS. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) FOR ARTERIAL CANNULA, SCISSORS ARE NOT TO BE USED AT OR NEAR THE INSERTION SITE. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE ON BROKEN CATHETER COULD NOT BE ESTABLISHED BASED ON THE ABOVE INVESTIGATION. THE COMPLAINT TREND WILL BE MONITORED.
BASED ON THE DHR REVIEW, THERE IS AN OUTGOING INSPECTION TO INSPECT FOR PRODUCT DAMAGED DURING THE IN-PROCESS INSPECTION AS PER MFG-079/B, NO CATHETER TUBING DEFECT QN BEING RAISE FOR THE ASSEMBLY NEEDLE (AN) BATCH USED TO PRODUCE THIS COMPLAINT BATCH. 7 PHOTOS WERE RECEIVED FOR THIS COMPLAINT. REFER TO ATTACHMENT A. BROKEN CATHETER WAS OBSERVED IN THE PHOTOS RECEIVED. NO SAMPLE WAS RECEIVED. IF THERE WAS A SAMPLE RECEIVED, THE BROKEN CATHETER CAN BE INVESTIGATED TO DETERMINE ITS CAUSE, THE COMPLAINT WILL BE RE-OPEN WHEN THERE IS A SAMPLE RECEIVED. THE COMPLAINT TREND WILL BE MONITORED.
BASED ON THE DHR REVIEW, THERE IS AN OUTGOING INSPECTION TO INSPECT FOR PRODUCT DAMAGED DURING THE IN-PROCESS INSPECTION AS PER (B)(4), NO CATHETER TUBING DEFECT QN BEING RAISE FOR THE ASSEMBLY NEEDLE (AN) BATCH USED TO PRODUCE THIS COMPLAINT BATCH. 7 PHOTOS WERE RECEIVED FOR THIS COMPLAINT. REFER TO ATTACHMENT A. BROKEN CATHETER WAS OBSERVED IN THE PHOTOS RECEIVED. NO SAMPLE WAS RECEIVED. IF THERE WAS A SAMPLE RECEIVED, THE BROKEN CATHETER CAN BE INVESTIGATED TO DETERMINE ITS CAUSE, THE COMPLAINT WILL BE RE-OPEN WHEN THERE IS A SAMPLE RECEIVED. THE COMPLAINT TREND WILL BE MONITORED.
H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
DURING THE REMOVAL OF THE RIGHT RADIAL ARTERIAL CATHETER I NOTICE THE CATHETER RUPTURE. NO IMMEDIATE CONSEQUENCES AS THE PATIENT WAS PROMPTLY ASSESSED BY THE SURGEON VASCULAR SURGEON WHO BY ULTRASOUND REVEALED THE REMAINING PIECE OF CATHETER AND THE PATENCY OF THE RADIAL ARTERY RIGHT. POSSIBLE DEFECT IN ARTERIAL CATHETER? ARTERIAL CANNULA 20G L.45MM WITH FLOSWITHC COD.682245. CAN YOU HELP ME UNDERSTAND HOW WE CAN PROCEED TO ASSESS THE CAUSE OF WHAT HAPPENED? CURRENTLY THE BATCHES IN STOCK ARE 3203332 AND 3203338. SOME ADDITIONAL INFORMATION ON THE DYNAMICS OF THE ACCIDENT: THE ARTERIAL CATHETER WAS PLACED AT THE OPERATING ROOM IN BLOCK A FOR INVASIVE MONITORING. ON REMOVAL A FEW HOURS AFTER PLACEMENT, IT WAS NOTED THAT THE DISTAL PORTION OF THE CATHETER WAS EMBOLISED. IT IS NOT POSSIBLE TO TRACE A CERTAIN BATCH NUMBER. LOTS 3203332 AND 3203338 WERE DELIVERED.
DURING THE REMOVAL OF THE RIGHT RADIAL ARTERIAL CATHETER I NOTICE THE CATHETER RUPTURE. NO IMMEDIATE CONSEQUENCES AS THE PATIENT WAS PROMPTLY ASSESSED BY THE SURGEON VASCULAR SURGEON WHO BY ULTRASOUND REVEALED THE REMAINING PIECE OF CATHETER AND THE PATENCY OF THE RADIAL ARTERY RIGHT. POSSIBLE DEFECT IN ARTERIAL CATHETER? ARTERIAL CANNULA 20G L.45MM WITH FLOSWITHC COD.682245. CAN YOU HELP ME UNDERSTAND HOW WE CAN PROCEED TO ASSESS THE CAUSE OF WHAT HAPPENED? CURRENTLY THE BATCHES IN STOCK ARE 3203332 AND 3203338. SOME ADDITIONAL INFORMATION ON THE DYNAMICS OF THE ACCIDENT: THE ARTERIAL CATHETER WAS PLACED AT THE OPERATING ROOM IN BLOCK A FOR INVASIVE MONITORING. ON REMOVAL A FEW HOURS AFTER PLACEMENT, IT WAS NOTED THAT THE DISTAL PORTION OF THE CATHETER WAS EMBOLISED. IT IS NOT POSSIBLE TO TRACE A CERTAIN BATCH NUMBER. LOTS 3203332 AND 3203338 WERE DELIVERED.
DURING THE REMOVAL OF THE RIGHT RADIAL ARTERIAL CATHETER I NOTICE THE CATHETER RUPTURE. NO IMMEDIATE CONSEQUENCES AS THE PATIENT WAS PROMPTLY ASSESSED BY THE SURGEON VASCULAR SURGEON WHO BY ULTRASOUND REVEALED THE REMAINING PIECE OF CATHETER AND THE PATENCY OF THE RADIAL ARTERY RIGHT. POSSIBLE DEFECT IN ARTERIAL CATHETER? ARTERIAL CANNULA 20G L.45MM WITH FLOSWITHC COD.682245. CAN YOU HELP ME UNDERSTAND HOW WE CAN PROCEED TO ASSESS THE CAUSE OF WHAT HAPPENED? CURRENTLY THE BATCHES IN STOCK ARE 3203332 AND 3203338. SOME ADDITIONAL INFORMATION ON THE DYNAMICS OF THE ACCIDENT: THE ARTERIAL CATHETER WAS PLACED AT THE OPERATING ROOM IN BLOCK A FOR INVASIVE MONITORING. ON REMOVAL A FEW HOURS AFTER PLACEMENT, IT WAS NOTED THAT THE DISTAL PORTION OF THE CATHETER WAS EMBOLISED. IT IS NOT POSSIBLE TO TRACE A CERTAIN BATCH NUMBER. LOTS 3203332 AND 3203338 WERE DELIVERED.
DURING THE REMOVAL OF THE RIGHT RADIAL ARTERIAL CATHETER I NOTICE THE CATHETER RUPTURE. NO IMMEDIATE CONSEQUENCES AS THE PATIENT WAS PROMPTLY ASSESSED BY THE SURGEON VASCULAR SURGEON WHO BY ULTRASOUND REVEALED THE REMAINING PIECE OF CATHETER AND THE PATENCY OF THE RADIAL ARTERY RIGHT. POSSIBLE DEFECT IN ARTERIAL CATHETER? ARTERIAL CANNULA 20G L.45MM WITH FLOSWITHC COD.682245. CAN YOU HELP ME UNDERSTAND HOW WE CAN PROCEED TO ASSESS THE CAUSE OF WHAT HAPPENED? CURRENTLY THE BATCHES IN STOCK ARE 3203332 AND 3203338. SOME ADDITIONAL INFORMATION ON THE DYNAMICS OF THE ACCIDENT: THE ARTERIAL CATHETER WAS PLACED AT THE OPERATING ROOM IN BLOCK A FOR INVASIVE MONITORING. ON REMOVAL A FEW HOURS AFTER PLACEMENT, IT WAS NOTED THAT THE DISTAL PORTION OF THE CATHETER WAS EMBOLISED. IT IS NOT POSSIBLE TO TRACE A CERTAIN BATCH NUMBER. LOTS 3203332 AND 3203338 WERE DELIVERED.
IT WAS REPORTED THAT BD ARTERIAL CANNULA 20G/45MM CATHETER BROKEN AFTER PLACEMENT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THE REMOVAL OF THE RIGHT RADIAL ARTERIAL CATHETER I NOTICE THE CATHETER RUPTURE. NO IMMEDIATE CONSEQUENCES AS THE PATIENT WAS PROMPTLY ASSESSED BY THE SURGEON VASCULAR SURGEON WHO BY ULTRASOUND REVEALED THE REMAINING PIECE OF CATHETER AND THE PATENCY OF THE RADIAL ARTERY RIGHT. POSSIBLE DEFECT IN ARTERIAL CATHETER? ARTERIAL CANNULA 20G L.45MM WITH FLOSWITHC COD.682245. CAN YOU HELP ME UNDERSTAND HOW WE CAN PROCEED TO ASSESS THE CAUSE OF WHAT HAPPENED? SOME ADDITIONAL INFORMATION ON THE DYNAMICS OF THE ACCIDENT: THE ARTERIAL CATHETER WAS PLACED AT THE OPERATING ROOM IN BLOCK A FOR INVASIVE MONITORING. ON REMOVAL A FEW HOURS AFTER PLACEMENT, IT WAS NOTED THAT THE DISTAL PORTION OF THE CATHETER WAS EMBOLISED. IT IS NOT POSSIBLE TO TRACE A CERTAIN BATCH NUMBER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2296019 | BD ARTERIAL CANNULA 20G/45MM | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON | 3203338 | 00382906822451 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |