ARROW CVC KIT: 3-LUMEN 8.5FR X 20CM
Report
- Report Number
- 3006425876-2022-00241
- Event Type
- Malfunction
- Date Received
- March 21, 2022
- Date of Event
- February 28, 2022
- Report Date
- February 28, 2022
- Manufacturer
- ARROW INTERNATIONAL LLC
- Product Code
- DQY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
QN#: (B)(4).
(B)(4). THE ACTUAL DEVICE WAS NOT RETURNED; HOWEVER, THE CUSTOMER PROVIDED A PHOTO FOR EVALUATION. THE COMPLAINT OF NEEDLE HUB BROKE SEPARATED DURING USE WAS ABLE TO BE CONFIRMED BY THE PHOTO. A COMPLETE VISUAL INSPECTION COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. THE CUSTOMER DID NOT PROVIDE A LOT NUMBER; THEREFORE, A DEVICE HISTORY RECORD REVIEW WAS PERFORMED BASED UPON A LOT NUMBER FROM THE SALES HISTORY DATA OF THE CUSTOMER. ONE RELEVANT FINDING WAS IDENTIFIED. A NON-CONFORMANCE WAS INITIATED FOR MATERIAL K-04300-019B THE FOLLOWING LOTS: 13C20D1845, 13C20D1844 , 13C20D1843, 13C20D1842, 13C20D1841, 13C20D0872, 13C20D0869, 13C20D0184, 13C20D0180 , 13C20D0182 AND 13C20G2376. THE DEFECT IS RELATED TO NEEDLE HUBS CRACKED DURING USE. THE INSTRUCTIONS FOR USE (IFU) PROVIDED WITH THIS KIT STATES, "INSERT INTRODUCER NEEDLE OR CATHETER/NEEDLE WITH ATTACHED SYRINGE OR ARROW RAULERSON SYRINGE (WHERE PROVIDED) INTO VEIN AND ASPIRATE. WARNING: DO NOT LEAVE OPEN NEEDLES OR UNCAPPED, UNCLAMPED CATHETERS IN CENTRAL VENOUS PUNCTURE SITE. AIR EMBOLISM CAN OCCUR IF AIR IS ALLOWED TO ENTER A CENTRAL VENOUS ACCESS DEVICE OR VEIN. PRECAUTION: DO NOT REINSERT NEEDLE INTO INTRODUCER CATHETER (WHERE PROVIDED) TO REDUCE RISK OF CATHETER EMBOLUS." THE CUSTOMER REPORT OF NEEDLE HUB BROKE AND SEPARATED DURING USE WAS CONFIRMED BY VISUAL INSPECTION OF THE CUSTOMER SUPPLIED PHOTO. HOWEVER, FULL COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED BASED ON THE POTENTIAL LOT WITH ONE RELEVANT FINDING. A NON-CONFORMANCE WAS INITIATED FOR MATERIAL K-04300-019B RELATED TO NEEDLE HUBS CRACKED DURING USE; HOWEVER, 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.
IT WAS REPORTED THAT "AS PART OF AN EMERGENCY OPERATION WITH AN INCREASING NEED FOR KA, A CENTRAL VENOUS ACCESS SUBCLAVIAN WAS PLACED ON THE LEFT, THE SYSTEM WAS ANATOMICAL (NO ULTRASOUND-GUIDED SYSTEM). THERE WAS NO CONTACT WITH DISINFECTANT OR MOISTURE ON THE NEEDLE, THE PUNCTURE WAS UNPROBLEMATIC, BUT THERE WAS NO REASONABLE BACKFLOW OF BLOOD. THE NEEDLE CONE WAS COMPLETELY SEPARATED FROM THE METAL NEEDLE, THIS SEPARATION BETWEEN THE NEEDLE AND PLASTIC CONE WAS ONLY NOTICED AS THERE WAS RESISTANCE DETERMINED DURING BOUGIENAGE. THE GUIDE WIRE WAS ALREADY IN PLACE, SO LUCKILY THE NEEDLE DIDN'T GO UNDER THE SKIN." IT WAS REPORTED THERE WAS NO PATIENT INJURY. THE PATIENT'S CONDITION IS "FINE."
IT WAS REPORTED THAT "AS PART OF AN EMERGENCY OPERATION WITH AN INCREASING NEED FOR KA, A CENTRAL VENOUS ACCESS SUBCLAVIAN WAS PLACED ON THE LEFT, THE SYSTEM WAS ANATOMICAL (NO ULTRASOUND-GUIDED SYSTEM). THERE WAS NO CONTACT WITH DISINFECTANT OR MOISTURE ON THE NEEDLE, THE PUNCTURE WAS UNPROBLEMATIC, BUT THERE WAS NO REASONABLE BACKFLOW OF BLOOD. THE NEEDLE CONE WAS COMPLETELY SEPARATED FROM THE METAL NEEDLE, THIS SEPARATION BETWEEN THE NEEDLE AND PLASTIC CONE WAS ONLY NOTICED AS THERE WAS RESISTANCE DETERMINED DURING BOUGIENAGE. THE GUIDE WIRE WAS ALREADY IN PLACE, SO LUCKILY THE NEEDLE DIDN'T GO UNDER THE SKIN." IT WAS REPORTED THERE WAS NO PATIENT INJURY. THE PATIENT'S CONDITION IS "FINE".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2365862 | ARROW CVC KIT: 3-LUMEN 8.5FR X 20CM | CATHETER, PERCUTANEOUS | DQY | ARROW INTERNATIONAL LLC | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |