ARROW CVC SET: 4-LUMEN 8.5FR X 16CM
Report
- Report Number
- 3006425876-2026-00093
- Event Type
- Malfunction
- Date Received
- February 5, 2026
- Date of Event
- January 6, 2026
- Report Date
- January 12, 2026
- Manufacturer
- ARROW INTERNATIONAL LLC
- Product Code
- DQY
- PMA / PMN Number
- K862056
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
QN# (B)(4). THE CUSTOMER RETURNED ONE IMAGE SHOWING A CONTENTS OF A CVC KIT. VISUAL ANALYSIS SHOWS THAT THE CATHETER JUNCTURE HUB AND THE CATHETER CLAMP ARE DIFFERENT COLORS THAN THE COMPONENTS INVOLVED WITH THIS EVENT; THEREFORE, IT IS ASSUMED THAT THE PHOTO WAS PROVIDED FOR REFERENCE ONLY. THE CUSTOMER ALSO RETURNED A 4-LUMEN CVC AS WELL AS ONE LOOSE CATHETER CLAMP (K-25854-003A) FOR ANALYSIS. THE CLAMP FASTENER COMPONENT WAS NOT RETURNED FOR ANALYSIS. SIGNS OF USE IN THE FORM OF WHAT APPEARS TO BE MEDICATION WERE OBSERVED INSIDE THE DISTAL EXTENSION LINE. VISUAL ANALYSIS OF THE RETURNED CATHETER AND CATHETER CLAMP DID NOT REVEAL ANY DEFECTS OR ANOMALIES. PER THE CUSTOMER REPORT, "WHILST REMOVING THE DRESSING, THE WINGED CLIP WAS STILL ATTACHED TO THE PATIENT'S SKIN. APPARENTLY, THERE WAS NO FIXATION ON THE FIXED WINGS OF THE CVC". THEREFORE, IT CAN BE CONCLUDED THAT THE CATHETER WAS LIKELY NOT PROPERLY SECURED; HOWEVER, A FULL VISUAL ANALYSIS COULD NOT BE PERFORMED ON THE CLAMP FASTENER AS IT WAS NOT RETURNED. THE OVERALL LENGTH OF THE CATHETER MEASURED 169MM, WHICH IS WITHIN THE SPECIFICATION LIMITS OF 157MM-177MM PER THE CATHETER PRODUCT DRAWING. THE CATHETER OUTER DIAMETER MEASURED 2.96MM, WHICH IS WITHIN THE SPECIFICATIONS OF 2.87MM-2.97MM PER THE CATHETER EXTRUSION PRODUCT DRAWING. THE CATHETER CLAMP INNER DIAMETER 0.110", WHICH IS WITHIN THE SPECIFICATIONS OF 0.108"-0.116" PER THE CATHETER CLAMP PRODUCT DRAWING. THE INNER DIAMETER OF THE BOX CLAMP FASTENER COULD NOT BE MEASURED AS IT WAS NOT RETURNED FOR ANALYSIS. FUNCTIONAL INSPECTION WAS PERFORMED PER THE INSTRUCTIONS FOR USE (IFU)PROVIDED WITH THIS KIT WHICH STATES, "USE A CATHETER STABILIZATION DEVICE, CATHETER CLAMP AND FASTENER, STAPLES OR SUTURES (WHERE PROVIDED). USE CATHETER HUB AS PRIMARY SECUREMENT SITE. USE CATHETER CLAMP AND FASTENER AS A SECONDARY SECUREMENT SITE AS NECESSARY". THE CATHETER CLAMP WAS ASSEMBLED TO THE CATHETER BODY. A LAB INVENTORY CLAMP FASTENER WAS THEN ASSEMBLED OVER THE CATHETER CLAMP. TO TEST THE AXIAL CLAMP HOLDING FORCE, THE BOX CLAMP ASSEMBLY WAS THEN ATTACHED TO A FORCE GAUGE. PER AMRQ-000145 REV05, GENERATION 1 COMBINATIONS OF THE CLAMP/FASTENER FOR CATHETERS LARGER THAN 7FR SHOULD SUSTAIN A WITHDRAWAL FORCE OF = 6N (1.35LBS). THE BOX CLAMP ASSEMBLY WAS PULLED IN THE DIRECTION OF THE CATHETER EXTRUSION UP TO 1.35 LBS OF FORCE. NO MOVEMENT OF THE CLAMP WAS OBSERVED. THEREFORE, THE CUSTOMER REPORT COULD NOT BE CONFIRMED AS NO ANOMALIES WERE IDENTIFIED IN REGARDS TO THE FUNCTIONALITY OF THE BOX CLAMP ASSEMBLY. FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED ON THE ACTUAL CLAMP FASTENER INVOLVED WITH THIS COMPLAINT AS IT WAS NOT RETURNED. THE IFU PROVIDED WITH THE KIT INFORMS THE USER, "USE A CATHETER STABILIZATION DEVICE, CATHETER CLAMP AND FASTENER, STAPLES OR SUTURES (WHERE PROVIDED). USE CATHETER HUB AS PRIMARY SECUREMENT SITE. USE CATHETER CLAMP AND FASTENER AS A SECONDARY SECUREMENT SITE AS NECESSARY". THE CUSTOMER REPORT OF A CATHETER MIGRATION COULD NOT BE CONFIRMED BASED ON INVESTIGATION OF THE RETURNED SAMPLE. VISUAL ANALYSIS OF THE CATHETER AND CLAMP CATHETER DID NOT REVEAL ANY DEFECTS OR ANOMALIES. A FULL VISUAL ANALYSIS COULD NOT BE PERFORMED ON THE CLAMP FASTENER AS IT WAS NOT RETURNED. ALTHOUGH THE CUSTOMER INDICATED THAT THE SUTURE WINGS WERE NOT SECURED WITH SUTURES, A FULL ANALYSIS COULD NOT BE PERFORMED WITHOUT THE CLAMP FASTENER ALSO RETURNED. THE RETURNED DEVICE MET ALL RELEVANT VISUAL AND DIMENSIONAL ANALYSES. LIKEWISE, FUNCTIONAL TESTING WITH A LAB INVENTORY CLAMP FASTENER CONFIRMED NO SLIPPAGE ON THE CONNECTION. BASED ON THE CUSTOMER REPORT AND THE RETURNED SAMPLE, THE CUSTOMER NOT UTILIZING BOTH THE PRIMARY AND SECONDARY SUTURE SITES LIKELY CONTRIBUTED TO THIS EVENT; HOWEVER, THE ROOT CAUSE CANNOT BE DETERMINED AS A FULL INVESTIGATION COULD NOT BE PERFORMED ON THE CLAMPS FASTENER. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR COMPLAINTS OF THIS NATURE.
(B)(4).
IT WAS REPORTED THAT "INCIDENT OCCURRED ON (B)(6) 2026. THE CENTRAL VENOUS CATHETER WAS FOUND ON THE PATIENT'S CHEST (OUTSIDE THE PATIENT'S BODY), WITH THE DRESSING STILL IN PLACE. WHILST REMOVING THE DRESSING, THE WINGED CLIP WAS STILL ATTACHED TO THE PATIENT'S SKIN. APPARENTLY, THERE WAS NO FIXATION ON THE FIXED WINGS OF THE CVC. ONGOING TREATMENTS WERE STOPPED. THE BLEEDING WAS OCCLUDED. A NEEDLE WAS INSERTED INTO THE PATIENT'S ARTERIOVENOUS FISTULA TO COMPLETE THE ANTI-GASTROINTESTINAL TREATMENT." THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "GOOD".
IT WAS REPORTED THAT "INCIDENT OCCURRED ON (B)(6) 2026. THE CENTRAL VENOUS CATHETER WAS FOUND ON THE PATIENT'S CHEST (OUTSIDE THE PATIENT'S BODY), WITH THE DRESSING STILL IN PLACE. WHILST REMOVING THE DRESSING, THE WINGED CLIP WAS STILL ATTACHED TO THE PATIENT'S SKIN. APPARENTLY, THERE WAS NO FIXATION ON THE FIXED WINGS OF THE CVC. ONGOING TREATMENTS WERE STOPPED. THE BLEEDING WAS OCCLUDED. A NEEDLE WAS INSERTED INTO THE PATIENT'S ARTERIOVENOUS FISTULA TO COMPLETE THE ANTI-GASTROINTESTINAL TREATMENT." THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "GOOD".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 29585 | ARROW CVC SET: 4-LUMEN 8.5FR X 16CM | CATHETER, PERCUTANEOUS | DQY | ARROW INTERNATIONAL LLC | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | NOT REPORTED| NOT REPORTED |