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	12/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: on (b)(6) 2023, the doctor found the luer hub/fitting has crack during use on the patient.Patient was reported as good post procedure.
Additional Manufacturer Narrative
(b)(4).The customer provided one image showing a connector assembly for analysis.Signs of use were observed on the sample.The customer returned one connector assembly, a compression cap, and compression sleeve.Signs of use were observed.Visual inspection of the compression cap confirmed there was a crack present adjacent to the molding seam.Microscopic examination confirmed the damage.It was also noted that the compression sleeve contained imprints.These imprints were likely caused from the sleeve becoming pinched between the threads of the connector cap and the connector assembly.R & d has previously been contacted as part of complaint investigations of this type.They confirmed that overtightening of the compression cap during use likely caused or contributed to this event.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not use if package has been previously opened or damaged"." 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." "ensure that 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.Remove catheter clamp".The report of a damaged compression cap was confirmed through complaint investigation.Visual analysis revealed a crack in the compression cap.Visual and microscopic examination also revealed thread imprints on the green compression sleeve, which likely occurred from being pinched between the connector assembly and compression cap.A device history record review was performed, and no relevant findings were identified.Based on the sample received, the report from the customer, and past comments from r & d, the root cause for this issue is likely due to unintentional use error.Teleflex will continue to monitor and trend for reports if this nature.
Event or Problem Description
It was reported that: (b)(6) 2023, the doctor found the luer hub/fitting has crack during use on the patient.Patient was reported as good post procedure.

• 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: 18500984
• Report Number: 9680794-2024-00020
• Device Sequence Number: 20784123
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2023

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 Expiration Date: 12/31/2024
• Device Catalogue Number: CS-15282-VSP
• Device Lot Number: 13F21M0039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2023
• Supplement Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 01/12/2024
• Supplement Report FDA Received Date: 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED.; NOT REPORTED.
• Patient Sex: Unknown