ARROW CVC SET: 5-LUMEN 8.5FR X 20CM
Report
- Report Number
- 3006425876-2025-01097
- Event Type
- Malfunction
- Date Received
- November 21, 2025
- Date of Event
- October 8, 2025
- Report Date
- October 31, 2025
- Manufacturer
- ARROW INTERNATIONAL LLC
- Product Code
- FOZ
- UDI-DI
- 00801902082251
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4). THE ACTUAL DEVICE WAS NOT RETURNED; HOWEVER, THE CUSTOMER PROVIDED ONE PHOTO FOR ANALYSIS. THE IMAGE SHOWS THREE NEEDLES, ONE WITH A SEPARATED CANNULA FROM THE HUB. THE REMAINING TWO NEEDLES ARE BENT ADJACENT TO THE HUB. SIGNS OF USE ARE OBSERVED IN THE FORM OF BIOLOGICAL MATERIAL. THE COMPLAINT OF A BROKEN NEEDLE CANNULA WAS ABLE TO BE CONFIRMED BY THE PHOTO; HOWEVER, A COMPLETE VISUAL INSPECTION TO EVALUATE THE CAUSE OF THE DAMAGE COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE INSTRUCTIONS FOR USE (IFU) PROVIDED WITH THIS KIT WARNS THE USER, "INSERT INTRODUCER NEEDLE OR CATHETER/NEEDLE WITH ATTACHED SYRINGE OR ARROW RAULERSON SYRINGE (WHERE PROVIDED) INTO VEIN AND ASPIRATE." WITHOUT THE DEVICE TO EVALUATE, THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.
QN#(B)(4). A RE-INVESTIGATION WAS PERFORMED AND THE INVESTIGATION CONCLUSION WAS UPDATED AS FOLLOWS: MORE TESTING WAS PERFORMED ON LAB INVENTORY CANNULAS (N5-04300-006A) PER SECTION 7.10 OF AMRQ-000061, WHICH STATES "WHEN TESTED IN ACCORDANCE WITH BS EN ISO 9626 ANNEX C, THE CANNULA SHALL NOT BREAK". THE TESTING SET-UP ON THE FULL NEEDLE ASSEMBLIES WAS PERFORMED TO EXCLUDE THE HUBS. ALL TESTS PASSED. BASED ON THE RESULTS, THE APPEARANCE OF THE DAMAGE IS CONSISTENT WITH A BEND THAT FURTHER LED TO SEPARATION. THE NEEDLE INVOLVED WITH THIS COMPLAINT (K-04300-033E) HAS A THIN WALL THAT MAKES IT SUSCEPTIBLE TO BREAKAGE IF FORCE IS APPLIED. THE REPORT OF A BENT NEEDLE CANNULA WAS CONFIRMED THROUGH ANALYSIS OF THE RETURNED SAMPLE AND SUPPLIED IMAGE. VISUAL ANALYSIS REVEALED THAT THE NEEDLE CANNULA SEPARATED ADJACENT TO THE HUB. THE CANNULA APPEARED BENT AND OVAL-SHAPED AT BOTH ENDS OF THE SEPARATION. UNDAMAGED PORTIONS OF THE NEEDLE CANNULA MET ALL RELEVANT DIMENSIONAL REQUIREMENTS. FURTHER COMMENTS AND TESTING FROM R & D AND MANUFACTURING REVEALED THAT THE NEEDLE CANNULAS MEET THE DESIGN REQUIREMENTS PER BS EN ISO 9626. THEREFORE, THERE IS NO INDICATOR THAT THE NEEDLE HAS ANY TYPE OF MANUFACTURING OR SUPPLIER DEFECT. BASED ON THE CUSTOMER REPORT, THE SAMPLE RECEIVED, AND COMMENTS FROM R & D/MANUFACTURING, THE ROOT CAUSE CANNOT BE DETERMINED AS IT IS UNKNOWN IF THE NEEDLE CANNULA WAS DAMAGED PRIOR TO CUSTOMER HANDLING. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.
QN# (B)(4). THE CUSTOMER PROVIDED ONE IMAGE SHOWING THREE 18GA INTRODUCER NEEDLES. SIGNS OF USE WERE OBSERVED ON ALL THREE NEEDLES. TWO NEEDLE CANNULAS APPEAR TO BE BENT. THE THIRD CANNULA IS COMPLETELY SEPARATED. THE CUSTOMER ALSO RETURNED ONE 18GA INTRODUCER NEEDLE WITH LIDSTOCK AND EIGHT UNOPENED CVC KITS. SIGNS OF USE WERE OBSERVED INSIDE THE NEEDLE HUB. VISUAL ANALYSIS REVEALED THAT THE NEEDLE CANNULA WAS SEPARATED ADJACENT TO THE HUB. A SLIGHT BEND WAS ALSO OBSERVED AROUND THE MIDDLE OF THE EXTRUSION. MICROSCOPIC EXAMINATION CONFIRMED THE DAMAGE AND REVEALED EVIDENCE OF DEFORMATION AT THE LOCATION OF THE SEPARATION. THIS INDICATED THAT THE CANNULA LIKELY BECAME BENT BEFORE IT FULLY SEPARATED. THE EIGHT UNOPENED KITS WERE OPENED TO BETTER ANALYZE THE 18GA INTRODUCER NEEDLES. NO DEFECTS OR ANOMALIES WERE OBSERVED ON ANY OF THE NEEDLES. THE SEPARATION ON THE CANNULA MEASURED 3MM FROM THE NEEDLE HUB. THE NEEDLE CANNULA OUTER DIAMETER MEASURED 0.050", WHICH IS WITHIN THE SPECIFICATION LIMITS OF 0.0495"-0.0505" PER THE CANNULA PRODUCT DRAWING. THE CANNULA INNER DIAMETER AT THE DISTAL AND PROXIMAL ENDS MEASURED 0.041", WHICH IS WITHIN THE SPECIFICATION LIMITS OF 0.041"-0.043" PER THE CANNULA PRODUCT DRAWING. THE NEEDLE HUB WAS ATTACHED TO A LAB INVENTORY ARROW RAULERSON SYRINGE (ARS). A LAB INVENTORY GUIDE WIRE (OUTER DIAMETER MEASURED 0.79MM) WAS THEN INSERTED THROUGH THE NEEDLE CANNULA. DESPITE THE DEFORMATION AT THE POINT OF SEPARATION, THE GUIDE WIRE WAS ABLE TO PASS COMPLETELY THROUGH THE NEEDLE. PERFORMED PER IFU STATEMENT, "ADVANCE GUIDEWIRE INTO ARROW RAULERSON SYRINGE APPROXIMATELY 10 CM UNTIL IT PASSES THROUGH SYRINGE VALVES OR INTO INTRODUCER NEEDLE". FOUR OF THE REPRESENTATIVE SAMPLES WERE SENT FOR FUNCTIONAL TESTING PER SECTION 7.10 OF AMRQ-000061, WHICH STATES "WHEN TESTED IN ACCORDANCE WITH BS EN ISO 9626 ANNEX C, THE CANNULA SHALL NOT BREAK". TWO OF THE FOUR SAMPLES FAILED WHEN TESTED UNDER NORMAL CONDITIONS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE IFU PROVIDED WITH THE KIT INFORMS THE USER, "DO NOT ALTER THE CATHETER, GUIDEWIRE OR ANY OTHER KIT/SET COMPONENT DURING INSERTION, USE OR REMOVAL". THE REPORT OF A BROKEN NEEDLE CANNULA WAS CONFIRMED THROUGH INVESTIGATION OF THE RETURNED SAMPLE. VISUAL ANALYSIS REVEALED THAT THE CANNULA WAS SEPARATED ADJACENT TO THE NEEDLE HUB. THE SAMPLE MET ALL RELEVANT DIMENSIONAL REQUIREMENTS; HOWEVER, FUNCTIONAL TESTING ON THE RETURNED REPRESENTATIVE SAMPLES PER BS EN ISO 9626 CONFIRMED INSTANCES OF FAILURE. BASED ON THE CUSTOMER REPORT, THE SAMPLE RECEIVED, AND THE ADDITIONAL TESTING PERFORMED, THE LIKELY ROOT CAUSE IS SUPPLIER RELATED. A NON-CONFORMANCE WAS INITIATED TO FURTHER INVESTIGATE THIS COMPLAINT ISSUE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.
(B)(4).
IT WAS REPORTED THAT "WHEN INSERTED INTO THE SUBCLAVIAN VEIN WITHOUT APPLYING EXCESSIVE FORCE, THE ASPIRATION CANNULA BENT UNUSUALLY SHARPLY IMMEDIATELY AFTER THE CONE, CAUSING THE CANNULA TO BREAK." THERE WAS NO PATIENT INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
IT WAS REPORTED THAT "WHEN INSERTED INTO THE SUBCLAVIAN VEIN WITHOUT APPLYING EXCESSIVE FORCE, THE ASPIRATION CANNULA BENT UNUSUALLY SHARPLY IMMEDIATELY AFTER THE CONE, CAUSING THE CANNULA TO BREAK." THERE WAS NO PATIENT INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
IT WAS REPORTED THAT "WHEN INSERTED INTO THE SUBCLAVIAN VEIN WITHOUT APPLYING EXCESSIVE FORCE, THE ASPIRATION CANNULA BENT UNUSUALLY SHARPLY IMMEDIATELY AFTER THE CONE, CAUSING THE CANNULA TO BREAK." THERE WAS NO PATIENT INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
IT WAS REPORTED THAT "WHEN INSERTED INTO THE SUBCLAVIAN VEIN WITHOUT APPLYING EXCESSIVE FORCE, THE ASPIRATION CANNULA BENT UNUSUALLY SHARPLY IMMEDIATELY AFTER THE CONE, CAUSING THE CANNULA TO BREAK." THERE WAS NO PATIENT INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 425242 | ARROW CVC SET: 5-LUMEN 8.5FR X 20CM | CATHETER INTRAVASCULAR THERAPY | FOZ | ARROW INTERNATIONAL LLC | IPN916867 | 71F25E0081 | 00801902082251 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |