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

Model Number	IPN055260
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: the catheter was inserted by the vascular surgeons on (b)(6) 2022.Since on (b)(6) 2022, the patient had hemodialysis sessions with this catheter.On (b)(6) 2022, the hemodialysis machine (alarm) rang and stopped due to the presence of an air bubble detected in the catheter.It was observed by the nursing team.This led to a re-hospitalization and prolonged hospitalization on (b)(6) 2022, the removal of the initial catheter and the insertion of a new catheter.Additional information received on 14oct2022: the catheter was inserted for chronic hemodialysis on (b)(6) 2022.The patient had a first hemodialysis session in intensive care on (b)(6) 2022 with success.Patient comes 3 times a week to the hospital for hemodialysis sessions.On (b)(6) 2022, the alarm rang , and the machine stopped as it detected air.On (b)(6) 2022, the patient had an intervention at the clinic.The catheter inserted in the first hospital in right jugular was removed a new one inserted in left jugular.There were no consequences for the patient because the machine stops when it detects air.
Additional Manufacturer Narrative
Qn# (b)(6).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 that: the catheter was inserted by the vascular surgeons on (b)(6) 2022.Since (b)(6) 2022, the patient had hemodialysis sessions with this catheter.On (b)(6) 2022, the hemodialysis machine (alarm) rang and stopped due to the presence of an air bubble detected in the catheter.It was observed by the nursing team.This led to a re-hospitalization and prolonged hospitalization on (b)(6) 2022, the removal of the initial catheter and the insertion of a new catheter.Additional information received on 14oct2022: the catheter was inserted for chronic hemodialysis on (b)(6) 2022.The patient had a first hemodialysis session in intensive care on (b)(6) 2022 with success.Patient comes 3 times a week to the hospital for hemodialysis sessions.On 17aug2022, the alarm rang , and the machine stopped as it detected air.On (b)(6) 2022, the patient had an intervention at the clinic.The catheter inserted in the first hospital in right jugular was removed a new one inserted in left jugular.There were no consequences for the patient because the machine stops when it detects air.

• 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: 15608975
• Report Number: 9680794-2022-00659
• Device Sequence Number: 7179313
• Product Code: MSD
• UDI-Device Identifier: 30801902155956
• UDI-Public: 30801902155956
• 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): 09/30/2022

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: 11/30/2023
• Device Model Number: IPN055260
• Device Catalogue Number: CS-15232-X
• Device Lot Number: 13F21H1096
• 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: 09/30/2022
• Supplement Date Received by Manufacturer: 11/17/2022
• Initial Report FDA Received Date: 10/14/2022
• Supplement Report FDA Received Date: 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2021
• 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: HEMODIALYSIS.; HEMODIALYSIS.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown