MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-L 15 FR X 23 CM; CATHETER HEMODIALYSIS IMPLANTE

Catalog Number	CSD-15282-SP
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The customer returned one, connector assembly, compression fitting/cap , compression sleeve, and the product lidstock for analysis.Signs of use were observed within the returned components.Visual analysis revealed the compression sleeve was damaged/torn within the compression fitting/cap.The damage to the compression sleeve is consistent with the compression sleeve being misplaced within the compressing fitting/cap which would result in the metal cannulas on the connector assembly to catch onto the edge of the compressing sleeve as the components are assembled.When the compression fitting/cap and sleeve are twisted onto the juncture hub, the compression sleeve can get damaged/caught in the threads resulting in a non-secure connection between the compression fitting and connector assembly.The instructions-for-use (ifu) provided with this kit instructs the user, "slide threaded compression cap over compression sleeve towards hub connection assembly with compression sleeve seated completely inside.Thread compression cap onto hub connection assembly firmly, but do not over tighten.There should be no threads visible on hub connection assembly." the threaded compression fitting/cap and returned compression sleeve were assembled onto the connector assembly and a non-secure connection was observed.The compression fitting was unable to fully twist onto the juncture hub and the juncture hub threads remained visible.The threaded compression fitting/cap and a lab inventory compression sleeve were assembled onto the connector.The threaded compression fitting/cap and compression sleeve assembled onto the connector assembly hub as intended.No threads of the juncture hub were visible after assembly.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 , "warning: green compression sleeve must be present when threading compression cap onto hub connection assembly.Failure to do so may result in air embolism, blood loss, or catheter separation.Precaution: 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 complaint of the threaded compression fitting/cap not connecting to the connector assembly was able to be confirmed through complaint investigation of the returned sample.The compression sleeve was damaged/torn upon return which is consistent with misalignment of the compression sleeve within the compression fitting/cap prior to twisting on the connector assembly.Based on the customer report and sample received, unintentional use error likely caused or contributed to the reported event.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported "r told me they attempted to twist the hub to lot and it would not lock, they had to open a 2nd kit." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 23 CM
• Common Device Name: CATHETER HEMODIALYSIS IMPLANTE
• 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: keona jones ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20781775
• Report Number: 9680794-2024-01145
• Device Sequence Number: 8948874
• Product Code: MSD
• UDI-Device Identifier: 20801902096634
• UDI-Public: (01)20801902096634(11)240114(17)261231(10)33F23K1087(21)
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K111117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/30/2024

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
• Device Catalogue Number: CSD-15282-SP
• Device Lot Number: 33F23K1087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2024
• 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
• Patient Sex: Male