MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-L 15 FR X 31 CM RETR; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number	CS-15312-VFE
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that; after placement of the catheter to the patient, the user was unable to connect the white compression cap of the tunneler to the irrigation tube, as the cap was loose.Therefore, the user removed the catheter and replaced with a new one.After inserting the new catheter without problem, the user attempted to connect the white compression cap of the tunneler to the irrigation tube, but he/she was unable to tighten the cap screw completely again.(the cap screw stopped at about 90% and could not be tightened further.) therefore, the catheter was removed and replaced with the third one to complete the procedure.Associated to 9680794-2023-00914.No patient injury was reported.
Additional Manufacturer Narrative
Qn# (b)(4).The customer report of connection difficulty between the catheter body and connector assembly was confirmed through investigation of the returned sample.As received, the fitting was not able to fully cover the threads from the connector assembly.Upon removal of the fitting, it was observed that the compression sleeve was partially advanced over the threads of the connector assembly.Damage was observed from the sleeve becoming pinched between the threads.Once the compression sleeve and fitting were removed and then reassembled according to the instructions-for-use, all relevant visual and functional requirements were met.A device history record review revealed no relevant findings.Based on the customer report and the sample received, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend on reports of this nature.
Event or Problem Description
It was reported that; after placement of the catheter to the patient, the user was unable to connect the white compression cap of the tunneler to the irrigation tube, as the cap was loose.Therefore, the user removed the catheter and replaced with a new one.After inserting the new catheter without problem, the user attempted to connect the white compression cap of the tunneler to the irrigation tube, but he/she was unable to tighten the cap screw completely again.(the cap screw stopped at about 90% and could not be tightened further.) therefore, the catheter was removed and replaced with the third one to complete the procedure.Associated to 9680794-2023-00914.No patient injury was reported.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 31 CM RETR
• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18208485
• Report Number: 9680794-2023-00915
• Device Sequence Number: 7467273
• Product Code: MSD
• UDI-Device Identifier: 10801902112870
• UDI-Public: 10801902112870
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141051
• 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): 10/31/2023

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: 07/31/2025
• Device Catalogue Number: CS-15312-VFE
• Device Lot Number: 13F22L0667
• 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: 10/31/2023
• Supplement Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 11/27/2023
• Supplement Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2022
• 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