MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-L 15 FR X 19 CM RETR; CATHETER, HEMODIALYSIS, IMPLA

Model Number IPN001348

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem Insufficient Information (4580)

Event Date 10/27/2022

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

The complaint is reported as: we observed a rigidity more important than usual on the "tubing" of the catheter which leads to a kink of the catheter linked to the clamps.On (b)(6) 2022, a patient faced this issue, with dialyses machine that stopped several times beacause of negative blood pressure (-300mmhg).This affects the blood flow, the quality of dialysis, the increase in the risk of coagulation, the patient's discomfort and delay in the department.

Event Description

The complaint is reported as: we observed a rigidity more important than usual on the "tubing" of the catheter which leads to a kink of the catheter linked to the clamps.On (b)(6) 2022, a patient faced this issue, with dialyses machine that stopped several times beacause of negative blood pressure (-300mmhg).This affects the blood flow, the quality of dialysis, the increase in the risk of coagulation, the patient's discomfort and delay in the department.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.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.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 19 CM RETR
• Type of Device: 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: 15831585
• MDR Text Key: 307810172
• Report Number: 9680794-2022-00763
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 10801902127171
• UDI-Public: 10801902127171
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K141051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/27/2022

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 Model Number: IPN001348
• Device Catalogue Number: CS-15192-VFE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/27/2022
• Initial Date FDA Received: 11/20/2022
• Supplement Dates Manufacturer Received: 12/14/2022
• Supplement Dates FDA Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: HEMODIALYSIS.; HEMODIALYSIS.