MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM; CATHETER HEMODIALYTSIS NON IMP

Model Number	IPN038320
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
The complaint is reported as: "during ongoing cica, pressure increased in the venous line.The dialysis was stopped as cica was no longer possible.When disconnecting a tubing-like material (approx.10 cm length) was pulled out of the line running towards the patient of the dialysis catheter.The material does not seem like coagulum but rather like rubber; the foreign material is secured and can be examined." it was reported the customer did not see the problem with the catheter, but with the dialysis machine from fresenius.
Additional Manufacturer Narrative
(b)(4).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
The complaint is reporeted as: "during ongoing cica, pressure increased in the venous line.The dialysis was stopped as cica was no longer possible.When disconnecting a tubing-like material (approx.10 cm length) was pulled out of the line running towards the patient of the dialysis catheter.The material does not seem like coagulum but rather like rubber; the foreign material is secured and can be examined." it was reported the customer did not see the problem with the catheter, but with the dialysis machine from fresenius.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
• Common Device Name: CATHETER HEMODIALYTSIS NON IMP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 12659786
• Report Number: 3006425876-2021-00968
• Device Sequence Number: 16471306
• Product Code: MPB
• UDI-Device Identifier: 10801902139204
• UDI-Public: 10801902139204
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K993933
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2021

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: 04/01/2022
• Device Model Number: IPN038320
• Device Catalogue Number: CS-25122-F
• Device Lot Number: 71F20H0284
• 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: 09/29/2021
• Supplement Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 10/19/2021
• Supplement Report FDA Received Date: 11/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2020
• 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
• Patient Sex: Unknown