MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS KIT: 2-L 15 FR X 23 CM; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number	CS-15282-VSP
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: on (b)(6) 2024, the connector cracked during the process of tightening the connector to the tubing.They were unable to withdraw the catheter during treatment and could only be fixed with sterile tape to temporarily maintain treatment." they were reported as fine.
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided two photos for analysis.The complaint of a cracked luer hub fitting was not able to be confirmed by the photos.The photos show the red luer hub from the connector assembly with evidence of use; however, a definitive crack was not visible.A complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.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 not confirmed by visual inspection of the customer supplied photos.The photos show the red luer hub from the connector assembly with evidence of use; however, a definitive crack was not visible.Full 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 probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "01 mar 2024, the connector cracked during the process of tightening the connector to the tubing.They were unable to withdraw the catheter during treatment and could only be fixed with sterile tape to temporarily maintain treatment." they were reported as fine.

• Brand Name: ARROW HEMODIALYSIS KIT: 2-L 15 FR X 23 CM
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLA
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• 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: 19002103
• Report Number: 9680794-2024-00292
• Device Sequence Number: 21187256
• Product Code: MSD
• UDI-Device Identifier: 00801902096388
• UDI-Public: 00801902096388
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Catalogue Number: CS-15282-VSP
• Device Lot Number: 13F21M0039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2024
• Supplement Date Received by Manufacturer: 04/22/2024
• Initial Report FDA Received Date: 03/29/2024
• Supplement Report FDA Received Date: 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown