MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CANNON II PLUS REPLACEMENT HUB SET; KIT, REPAIR, CATHETER, HEMODI

Catalog Number CAR-02800

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/22/2021

Event Type  malfunction  

Event Description

It was reported the luer hub was found cracked during hemodialysis.No patient harm reported.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Qn#: (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

It was reported the luer hub was found cracked during hemodialysis.No patient harm reported.The patient's condition is reported as fine.

Event Description

It was reported the luer hub was found cracked during hemodialysis.No patient harm reported.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).The customer returned a connector assembly for evaluation.Signs of use in the form of biological material were observed inside both extension lines.Visual analysis revealed the venous (blue) luer hub was cracked and contained scratches on the body.The damage appeared consistent with repeated tightening on the luer.The instructions for use (ifu) provided with this kit states, "flush both lumens of catheter with saline and clamp irrigation tube with catheter pinch clamp".The connector assembly was functionally tested by injecting both lumens using a water-filled lab inventory 10ml syringe.Water leaked from the cracked hub when injected with water.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".The customer report of a cracked luer hub was confirmed by complaint investigation of the returned sample.Visual analysis revealed that the venous luer hub was cracked and contained multiple scratches.The appearance of the crack was consistent with over-tightening on the luer hub.A device history record review was performed with no relevant findings.Based on the customer report and the condition of the sample received, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW CANNON II PLUS REPLACEMENT HUB SET
• Type of Device: KIT, REPAIR, CATHETER, HEMODI
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 13310220
• MDR Text Key: 286594170
• Report Number: 9680794-2022-00008
• Device Sequence Number: 1
• Product Code: NFK
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K020430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: CAR-02800
• Device Lot Number: 13F20D0293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: HEMODIALYSIS.; HEMODIALYSIS.; HEMODIALYSIS.