ARROW INTERNATIONAL LLC CANNON II PLUS REPLACEMENT HUB SET; KIT, REPAIR, CATHETER, HEMODI
|
Back to Search Results |
|
Catalog Number CAR-02400 |
Device Problem
Crack (1135)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/31/2024 |
Event Type
malfunction
|
Event Description
|
It was reported that: "(b)(6) 2024, the luer hub was found cracked during use on the patient.The patient was reported as fine.
|
|
Manufacturer Narrative
|
(b)(4).
|
|
Manufacturer Narrative
|
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The instructions for use (ifu) provided with this kit warns the user, "repeated over tightening of bloodlines, syringes and caps will reduce connector life and could lead to potential connector failure".A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
|
|
Event Description
|
It was reported that: "10 jan 2024, the luer hub was found cracked during use on the patient.The patient was reported as fine.
|
|
Search Alerts/Recalls
|
|
|