ARROW ARTERIAL CATHETERIZATION KIT: 18 GA X 6"
Report
- Report Number
- 9680794-2022-00276
- Event Type
- Injury
- Date Received
- May 4, 2022
- Date of Event
- April 9, 2022
- Report Date
- April 12, 2022
- Manufacturer
- ARROW INTERNATIONAL LLC
- Product Code
- DQX
- UDI-DI
- 50801902117644
- PMA / PMN Number
- K810675
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4).
QN# (B)(4). THE CUSTOMER RETURNED ONE ARTERIAL CATHETER FOR ANALYSIS. SIGNS OF USE IN THE FORM OF BIOLOGICAL MATERIAL WAS OBSERVED INSIDE THE CATHETER BODY. VISUAL ANALYSIS REVEALED THAT THE CATHETER BODY BECAME SEPARATED DIRECTLY ADJACENT TO THE HUB. MICROSCOPIC EXAMINATION CONFIRMED THE DAMAGE AND REVEALED THAT THE EDGES WERE SMOOTH AND UNIFORM. THE APPEARANCE OF THE DAMAGE IS CONSISTENT WITH DAMAGE RESULTING FROM CONTACT WITH A SHARP INSTRUMENT (I.E. SCISSORS, SCALPE, ETC.). IT WAS ALSO OBSERVED THAT THE CATHETER WAS SEPARATED DIRECTLY ADJACENT TO THE DISTAL TIP. THIS SEPARATED TIP WAS NOT RETURNED FOR ANALYSIS. THE CATHETER WAS SEPARATED APPROXIMATELY 1MM FROM THE HUB. THE SEPARATION TOWARDS THE TIP MEASURED APPROXIMATELY 163MM FROM THE SEPARATION ADJACENT TO THE HUB. DESPITE THAT A PORTION OF THE CATHETER TIP NOT RETURNED BY THE CUSTOMER, THE CATHETER BODY TOTAL LENGTH MEASURED 6 1/16" WHICH IS WITHIN THE SPECIFICATION LIMITS OF 5 13/16"-6 3/16" PER THE CATHETER PRODUCT DRAWING. THE CATHETER BODY OUTER DIAMETER MEASURED .057" WHICH IS WITHIN THE SPECIFICATION LIMITS OF .055"-.059" PER THE CATHETER EXTRUSION PRODUCT DRAWING. THE CATHETER BODY INNER DIAMETER AT THE PROXIMAL END MEASURED .037" WHICH IS WITHIN THE SPECIFICATION LIMITS OF .037"-.039" PER THE CATHETER EXTRUSION PRODUCT DRAWING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE IFU PROVIDED WITH THE KIT INFORMS THE USER, "ONCE THE CATHETER IS PARTIALLY THREADED OFF THE NEEDLE, DO NOT ATTEMPT TO ADVANCE NEEDLE INTO CATHETER AGAIN - THIS MAY CAUSE CATHETER DAMAGE." THE REPORT OF A SEPARATED ARTERIAL CATHETER WAS CONFIRMED THROUGH COMPLAINT INVESTIGATION. VISUAL AND MICROSCOPIC ANALYSIS REVEALED THAT THE CATHETER BODY WAS SEPARATED ADJACENT TO THE CATHETER HUB. THE APPEARANCE OF THE SEPARATION APPEARS SMOOTH AND UNIFORM AND IS CONSISTENT WITH DAMAGE RESULTING FROM CONTACT WITH A SHARP INSTRUMENT (I.E. SCISSORS, SCALPEL, ETC.). THE CATHETER MET ALL RELEVANT DIMENSIONAL REQUIREMENTS, AND A DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY RELEVANT FINDINGS. BASED ON THE CUSTOMER REPORT THAT THE DEFECT WAS OBSERVED DURING USE AND THE APPEARANCE OF THE DAMAGE, UNINTENTIONAL USE ERROR LIKELY CAUSED OR CONTRIBUTED TO THIS EVENT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.
IT WAS REPORTED THE PRODUCT WAS BEING REMOVED AS THERAPY WAS DONE. THE NURSE PULLED THE HUB FROM CATHETER BODY AND THE BODY "LODGED IN THE VEIN". THE PATIENT WAS SENT TO INTERVENTIONAL RADIOLOGY AND THE CATHETER WAS SUCCESSFULLY REMOVED. THE PATIENT'S CONDITION IS REPORTED TO BE FINE.
IT WAS REPORTED THE PRODUCT WAS BEING REMOVED AS THERAPY WAS DONE. THE NURSE PULLED THE HUB FROM CATHETER BODY AND THE BODY "LODGED IN THE VEIN". THE PATIENT WAS SENT TO INTERVENTIONAL RADIOLOGY AND THE CATHETER WAS SUCCESSFULLY REMOVED. THE PATIENT'S CONDITION IS REPORTED TO BE FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1317892 | ARROW ARTERIAL CATHETERIZATION KIT: 18 GA X 6" | WIRE, GUIDE, CATHETER | DQX | ARROW INTERNATIONAL LLC | IPN036984 | 13F22A0877 | 50801902117644 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |