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

Model Number	IPN920517
Medical Device Problem Codes	Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "a leak was observed on the replaceable hub connector and the fixation ring at the end of insertion after the connecting the 2 parts.The user reported that it was impossible to fully connect the 2 parts.Therefore , the user had to use a replacement kit to finish the procedure, causing delay.No other problem reported.".
Event or Problem Description
It was reported that: "a leak was observed on the replaceable hub connector and the fixation ring at the end of insertion after the connecting the 2 parts.The user reported that it was impossible to fully connect the 2 parts.Therefore , the user had to use a replacement kit to finish the procedure, causing delay.No other problem reported.".
Additional Manufacturer Narrative
(b)(4).Section d.4.Unique identifier (udi)# corrected from (b)(4).The customer provided one photo for analysis; the photo shows a disassembled hemodialysis connector.The customer returned one hemodialysis catheter connector, including the threaded com-pression cap and compression sleeve, for analysis.The catheter body was not returned for analysis.It was observed that the compression cap was not fully threaded onto the connector.The cap and compression sleeve were removed and replaced, and the cap was able to be fully threaded to the connector.After failing functional testing, a leak was observed where the metal prongs meet the juncture hub of the connector assembly.A leak test was performed on the connector assembly.With the distal ends of the metal prongs occluded, water was injected using a lab inventory 10ml syringe through each of the extension lines.When injecting water through both lumens, a leak was observed at the connection point between the metal prongs and the juncture hub.A device history record re-view was performed with no relevant findings.The instructions-for-use (ifu) provided with the kit informs the user "ensure compression sleeve is securely positioned inside threaded compression cap.Avoid attempts to place compression sleeve onto hub connection assembly cannula and then apply threaded compression cap.Incomplete compression may occur causing catheter separation." the customer report of a connector leak was confirmed through complaint investigation of the returned sample.A leak was observed at the connection point between the juncture hub and the metal prongs.Based on the condition of the returned device and the customer description, manufacturing caused or con-tributed to this event.Non-conformance was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for complaints of this nature.

• 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19653574
• Report Number: 9680794-2024-00630
• Device Sequence Number: 6914306
• Product Code: MSD
• UDI-Device Identifier: 00801902096302
• UDI-Public: 00801902096302
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K111117
• Number of Events Summarized: 1
• Summary Report (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): 06/05/2024

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: 09/30/2026
• Device Model Number: IPN920517
• Device Catalogue Number: CS-15232-X
• Device Lot Number: 33F23K0171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2024
• Supplement Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown