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

Model Number	IPN055260
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	12/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "incident happened on (b)(6) 2021.The tightening ring broke in half (despite being screwed as usual).During the session, the circuit filled with air and a very large hematoma formed in the subcutaneous tunnel." it was reported the patient is fine and the hematoma is fading away.The device was removed.
Event or Problem Description
It was reported that: "incident happened on (b)(6) 2021.The tightening ring broke in half (despite being screwed as usual).During the session, the circuit filled with air and a very large hematoma formed in the subcutaneous tunnel.".It was reported the patient is fine and the hematoma is fading away.The device was removed.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
It was reported that: "incident happened on 16 december 2021.The tightening ring broke in half (despite being screwed as usual).During the session, the circuit filled with air and a very large hematoma formed in the subcutaneous tunnel." it was reported the patient is fine and the hematoma is fading away.The device was removed.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one 2-lumen hemodialysis catheter for evaluation.Visual examination revealed that the compression sleeve and compression cap were partly threaded on the connector assembly.The portion of the compression sleeve that was over the threads of the hub connection assembly was torn.No other defects or anomalies were found.The luer injection port and the compression cap contained no cracks or damage.Microscopic examination confirmed the tear in the compression sleeve.The inner diameter of the compression sleeve measured.212" which is within specification of.207-.213" per product drawing.The outer diameter measured.2625" which is within specification of.257-.263" per product drawing.The catheter was tested using a pressurized leak tester with the compression sleeve and cap fully threaded on the connector assembly.The returned catheter body was clamped and the lumens were connected to the lab leak tester.The sample was tested per bs en iso 10555-1, section 4.7.1 (amrq-000162 rev.04) which states, "there shall be no liquid leakage in the form of a falling drop of water at 300-320 kpa (43.5-46.4 psi) for 30 sec when tested per bs en iso-10555-1 annex c." the leak tester was pressurized to 300 kpa and held for 30 seconds.No leaks were observed.The compression cap was inserted over the compression sleeve towards the connection assembly and connected firmly.The cap was able to be reconnected as expected.A manual tug test on the connection was completed and the connection was secure.A device history record review was performed with no relevant findings.The instructions for use (ifu) provided with this kit informs the user , "green compression sleeve must be present when threading compression cap onto hub connection assembly.Failure to do so may result in air embolism, blood loss or catheter separation." 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 customer report of a defect in the compression sleeve could be confirmed by complaint investigation of the returned sample.The catheter passed all relevant visual and functional testing, and a device history record review was performed with no relevant findings.Leak testing was performed on the returned catheter per bs en iso 10555-1, section 4.7.1 and no leaks were observed.No problem was found on the sample during testing, however, the catheter was returned with a torn compression sleeve and cap not threaded completely.Based on these circumstances, unintentional use error likely caused or contributed to the reported issue.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW HEMODIALYSIS KIT: 2-L 15 FR X 23 CM
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLA
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• 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: 13201050
• Report Number: 9680794-2022-00022
• Device Sequence Number: 5934470
• 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,Followup
• Report Date (Section B): 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2021
• Supplement Date Received by Manufacturer: 02/03/2022; 06/21/2022
• Initial Report FDA Received Date: 01/09/2022
• Supplement Report FDA Received Date: 02/03/2022; 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: NOT REPORTED; NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown