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	Insufficient Information (4580)
Date of Event	01/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported air entered the dialysis circuit.The "fixation ring (luer hub) was not positioned correctly and thus was not properly providing the seal (leak)".The luer hub and ring were replaced.No patient harm was reported.
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one connector assembly and a portion of the green sleeve from a chronic hemodialysis set for analysis.Signs of use in the form of biological material was observed on the connector assembly.Visual analysis of the connector assembly revealed that the green sleeve was damaged and was located over the threads of the connector assembly.The damage to the sleeve seems consistent with the sleeve becoming pinched between the threads and the compression fitting.It is possible for the observed damage to contribute to leaking at the juncture between the catheter body and the connector assembly; however, this cannot be officially confirmed without the rest of the sleeve, the compression fitting, and the catheter body returned for analysis.No other defects or anomalies were observed with the returned device.The arterial and venous extension lines were flushed with a lab inventory syringe.No defects or anomalies were observed as the fluid exited out of the respective cannulas.The cannulas were occluded at the distal end and the extension lines were flushed a second time.No leaks or anomalies were observed.The damaged green sleeve was removed from the assembly, and a lab inventory compression fitting and green sleeve were inserted over the cannulas.No defects or anomalies were observed as the sleeve/fitting threaded completely onto the connector assembly as intended.No threads from the connector assembly were visible.High pressure leak testing could not be performed as the green sleeve, connector fitting, nor the catheter body were returned for analysis.Performed per ifu statement, "flush catheter thoroughly with normal saline to remove residual blood, post-treatment and before instilling heparin".A device history record review was performed, and a relevant finding was identified.A non-conformance was initiated for batches 13p20k0207 and 13p20j0679 to address a damaged compression cap/fitting.Despite this, it cannot be confirmed if this is the same issue involved with this complaint as the connector fitting , green sleeve, and catheter body were not returned for analysis.The ifu provided with the kit informs the user, "slide threaded compression cap over compression sleeve towards hub connection assembly with compression sleeve seated completely inside".The ifu also states, "thread compression cap onto hub connection assembly firmly, but do not over tighten.There should be no threads visible on hub connection assembly".The report of a luer hub/fitting connection leak could not be confirmed through complaint investigation.Visual analysis revealed that the green sleeve was damaged and was over the connector assembly threads.This could have contributed to additional damage/leaking at the connection point; however, this cannot be confirmed and without the entire green sleeve and connector tubing returned for analysis.Functional testing did not reveal any defects or anomalies with the connector tubing; however, high-pressure leak testing could not be performed without the catheter body available for analysis.A device history record review was performed, and a relevant finding was identified.Based on the customer report and the sample received, the root cause cannot be confirmed without the entire assembly returned for analysis.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported air entered the dialysis circuit.The "fixation ring (luer hub) was not positioned correctly and thus was not properly providing the seal (leak)".The luer hub and ring were replaced.No patient harm was reported.

• 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: 13529261
• Report Number: 9680794-2022-00092
• Device Sequence Number: 17474042
• 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): 01/26/2022

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: 10/31/2023
• Device Model Number: IPN055260
• Device Catalogue Number: CS-15232-X
• Device Lot Number: 13F20K0877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2022
• Supplement Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 02/14/2022
• Supplement Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2020
• 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