ARROW CVC SET: 5-LUMEN 9.5FR X 20CM
Report
- Report Number
- 3006425876-2025-01019
- Event Type
- Injury
- Date Received
- November 5, 2025
- Date of Event
- October 8, 2025
- Report Date
- October 8, 2025
- Manufacturer
- ARROW INTERNATIONAL LLC
- Product Code
- DQY
- UDI-DI
- 10801902083019
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4). THE CUSTOMER RETURNED ONE DILATOR AND THE PRODUCT LIDSTOCK FOR ANALYSIS. NO DEFINITE SIGNS OF USE WERE OBSERVED. VISUAL AND MICROSCOPIC ANALYSIS CONFIRMED THAT A PORTION OF THE DILATOR TIP WAS SEPARATED. THE SEPARATED PORTION WAS NOT RETURNED. NO WIDENING, STRETCHING, OR EVIDENCE OF SIGNIFICANT PLASTIC DEFORMATION WAS IDENTIFIED. MICROSCOPIC EXAMINATION CONFIRMED THE DAMAGE AND REVEALED WHITE STRESS MARKS ALONG THE SEPARATION EDGES AND ON THE OUTSIDE OF THE TIP. THE SEPARATION EDGES WERE JAGGED AND SERRATED IN NATURE WHICH MAY BE INDICATIVE OF TEARING DURING USE. NO OTHER DEFECTS OR ANOMALIES WERE OBSERVED. THE LENGTH OF THE DILATOR FROM THE HUB TO THE DISTAL TIP MEASURED 3 15/16", WHICH IS WITHIN THE SPECIFICATION LIMITS OF 3 3/4"-4 1/4" PER DILATOR PRODUCT DRAWING. THE INNER DIAMETER OF THE DILATOR AT THE DISTAL TIP COULD NOT BE ACCURATELY MEASURED DUE TO THE NATURE OF THE DAMAGE. THE DILATOR WAS FUNCTIONALLY TESTED PER THE PRODUCT INSTRUCTIONS FOR USE (IFU). THE IFU PROVIDED WITH THIS KIT INSTRUCTS THE USER, "USE TISSUE DILATOR TO ENLARGE TISSUE TRACT TO THE VEIN AS REQUIRED. FOLLOW THE ANGLE OF THE GUIDEWIRE SLOWLY THROUGH THE SKIN." A LAB INVENTORY 0.826 MM GUIDE WIRE (MEASURED 0.796) WAS THREADED THROUGH THE DILATOR AND ADVANCED THROUGH WITH LITTLE TO NO RESISTANCE. R & D ENGINEERING, CLINICAL AND MEDICAL AFFAIRS (CMA), AND THE MANUFACTURING TEAM WERE PREVIOUSLY CONSULTED REGARDING THIS COMPLAINT. A CROSS-FUNCTIONAL REVIEW OF THE RETURNED SAMPLE DETERMINED THAT THE DAMAGE OBSERVED IS INCONSISTENT WITH CLINICIAN USE ALONE. THE MANUFACTURING TEAM CONFIRMED THAT THEY HAVE NOT SEEN THIS TYPE OF DAMAGE PRESENTED ON A DILATOR DURING IN-PROCESS 100% INSPECTION OF DILATOR TIPS. THE ENTIRE MANUFACTURING PROCESS FOR DILATOR PART NUMBER KU-24854-002 WAS REVIEWED, AND THE DAMAGE OBSERVED ON THE RETURNED SAMPLE DID NOT APPEAR CONSISTENT WITH DEFECTS RELATED TO THE MANUFACTURING PROCESS. HOWEVER, BASED ON THE SAMPLE RECEIVED AND CONSULTATION FROM ALL PARTIES, IT WAS DETERMINED THAT A NONCONFORMANCE WILL BE INITIATED AT THE MANUFACTURING SITE TO FURTHER EVALUATE THE ISSUE. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS TO SUGGEST A MANUFACTURING ISSUE. THE IFU PROVIDED WITH THIS KIT WARNS THE USER, "DO NOT USE EXCESSIVE FORCE WHEN INTRODUCING GUIDEWIRE OR TISSUE DILATOR AS THIS CAN LEAD TO VESSEL PERFORATION, BLEEDING, OR COMPONENT DAMAGE." THE CUSTOMER REPORT OF DILATOR TIP DAMAGE AND SEPARATION DURING USE WAS CONFIRMED THROUGH COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. VISUAL ANALYSIS REVEALED THAT A PORTION OF THE DILATOR TIP WAS SEPARATED. THE SEPARATED TIP WAS NOT RETURNED. MICROSCOPIC EXAMINATION CONFIRMED THE DAMAGE AND REVEALED WHITE STRESS MARKS ALONG THE SEPARATION EDGES AND ON THE OUTSIDE OF THE TIP WITH INDICATIONS OF A STRESS RELATED FRACTURE. R & D ENGINEERING, CLINICAL AND MEDICAL AFFAIRS (CMA), AND THE MANUFACTURING TEAM WERE CONSULTED REGARDING THIS COMPLAINT. A CROSS-FUNCTIONAL REVIEW OF THE RETURNED SAMPLE DETERMINED THAT THE DAMAGE OBSERVED IS INCONSISTENT WITH CLINICIAN USE ALONE. THE MANUFACTURING TEAM CONFIRMED THAT THEY HAVE NOT SEEN THIS TYPE OF DAMAGE PRESENTED ON A DILATOR. THE ENTIRE MANUFACTURING PROCESS FOR DILATOR PART NUMBER KU-24854-002 WAS REVIEWED, AND THE DAMAGE OBSERVED ON THE RETURNED SAMPLE DID NOT APPEAR CONSISTENT WITH DEFECTS RELATED TO THE MANUFACTURING PROCESS. BASED ON THESE CIRCUMSTANCES, THE ROOT CAUSE IS UNDETERMINED; HOWEVER, A NON-CONFORMANCE WAS INITIATED TO FURTHER INVESTIGATE THIS ISSUE AT THE MANUFACTURING PLANT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.
QN# (B)(4).
IT WAS REPORTED "DOCTOR REMOVED DILATOR AND NOTICED THE FRACTURED TIP. ESCALATED TO ICU CONSULTANT. CVC INSERTED WITHOUT ISSUE, VASCULAR CONTACTED REMOVAL OF FOREIGN BODY. XRAY DID NOT SHOW THE LOCATION OF THE FOREIGN BODY. NO FURTHER ACTION TAKEN OTHER OBSERVATION OF PATIENT." THE PATIENT'S CURRENT CONDITION IS UNKNOWN AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER; HOWEVER, FURTHER DETAILS HAVE NOT BEEN PROVIDED AT THIS TIME.
IT WAS REPORTED "DOCTOR REMOVED DILATOR AND NOTICED THE FRACTURED TIP. ESCALATED TO ICU CONSULTANT. CVC INSERTED WITHOUT ISSUE, VASCULAR CONTACTED REMOVAL OF FOREIGN BODY. XRAY DID NOT SHOW THE LOCATION OF THE FOREIGN BODY. NO FURTHER ACTION TAKEN OTHER OBSERVATION OF PATIENT." THE PATIENT'S CURRENT CONDITION IS UNKNOWN AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER; HOWEVER, FURTHER DETAILS HAVE NOT BEEN PROVIDED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2606924 | ARROW CVC SET: 5-LUMEN 9.5FR X 20CM | CATHETER, PERCUTANEOUS | DQY | ARROW INTERNATIONAL LLC | 71F23F1827 | 10801902083019 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | NOT REPORTED |