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

Model Number	IPN920517
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "a micro air bubble was observed on the dialysis circuit.Micro hole in the arterial line of the catheter.No dialysis done on that day and rescheduled for the 15th january with the replacement of part of the device." additional information was requested from the customer; however, no information has been provided at this time.
Additional Manufacturer Narrative
(b)(4).Udi#: (b)(4).Additional information received 24may2024 indicates the condition of the patient is "fine", and no medical intervention was required.It was also reported that "the problem was solved by removing the distal part (arterial line - red line) of the faulty catheter and replacing it with a new one from another device.Given the invasive nature of dialysis catheter placement, a second operation was not carried out." complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and 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 "a micro air bubble was observed on the dialysis circuit.Micro hole in the arterial line of the catheter.No dialysis done on that day and rescheduled for the 15th january with the replacement of part of the device.".

• Brand Name: 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: 19350413
• Report Number: 9680794-2024-00477
• Device Sequence Number: 7148189
• Product Code: MSD
• UDI-Device Identifier: 00801902096302
• UDI-Public: 00801902096302
• Combination Product (Y/N): N
• PMA/510(K) Number: K111117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2024

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: 06/30/2026
• Device Model Number: IPN920517
• Device Catalogue Number: CS-15232-X
• Device Lot Number: 33F23F0722
• 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: 04/29/2024
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2023
• 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: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown