MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-L 15 FR X 27 CM RETR; CATHETER, HEMODIALYSIS, IMPLA

Model Number IPN055270

Device Problems Leak/Splash (1354); Air/Gas in Device (4062)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/08/2023

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported that: "non-occlusive ring and unscrewed olive.Air bubble in circuit and catheter." the connection was leaking air.The catheter was inserted in the left internal jugular vein.No patient harm was reported.The dialysis procedure was delayed and the catheter was removed.The patient's current condition is reported as "stable".

Manufacturer Narrative

(b)(4).The customer returned one chronic hemodialysis catheter assembly for analysis.Signs of use in the form of biological material were observed.Initial visual inspection of the connector assembly and catheter body did not reveal any defects or anomalies.The compression fitting was threaded off the connector assembly, and the green compression sleeve was observed to be partially threaded on the hub of the connector assembly.The compression sleeve also appeared to be slightly torn, which is consistent with undue force applied.These factors likely contributed to the fitting between the catheter body and connector assembly.Amrq-000075 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." prior to reassembling the catheter assembly, the luer hubs were connected to the leak tester and pressurized to 300kpa while the distal end of the catheter was occluded.The connection did not feel entirely secure, and leaking was observed at the connection between the catheter body and connector assembly.However, once reassembled, the catheter assembly was flushed again, and no leaks were observed.Additionally, the connection between the connector assembly and catheter body felt secure.The catheter was also functionally tested per the instructions for use (ifu).The ifu provided with this kit states, "slide threaded compression cap and compression sleeve (pre-loaded on tunneler handle) onto catheter and beyond cut mark".When the catheter was assembled with the green compression sleeve and flushed with a lab inventory syringe filled with water, no leaks were detected.A device history record review was performed, and a potentially relevant finding was identified.Further review of the finding revealed that it was not relevant to the event.The instructions for use (ifu) provided with the kit instructs the user to use the green compression sleeve as part of the completing the catheter insertion: "slide threaded compression cap and compression sleeve (pre-loaded on tunneler handle) onto catheter and beyond cut mark." the ifu also warns, "caution: ensure compression sleeve is securely positioned inside threaded compression cap.Avoid attempts to place compression sleeve onto hub connection assembly cannula and then apply threaded compression cap.Incomplete compression may occur causing catheter separation.".The customer report of an insecure connection between the cath body and connector assembly was confirmed through investigation of the returned sample.It was observed that the compression sleeve was partially threaded on the connector assembly hub, and appeared slightly damaged.As received, the connection felt loose and catheter assembly did not pass functional testing.Once the compression sleeve and fitting were reassembled, the catheter assembly passed all relevant functional requirements.Additionally, once reassembled, the connection between the cath body and connector assembly was snug.A device history record review revealed no relevant findings.Based on the customer report and the sample received, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend on reports of this nature.

Event Description

It was reported that: "non-occlusive ring and unscrewed olive.Air bubble in circuit and catheter." the connection was leaking air.The catheter was inserted in the left internal jugular vein.No patient harm was reported.The dialysis procedure was delayed and the catheter was removed.The patient's current condition is reported as "stable".

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 27 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: 17722452
• MDR Text Key: 323107887
• Report Number: 9680794-2023-00641
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 10801902127355
• UDI-Public: 10801902127355
• 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: 08/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: IPN055270
• Device Catalogue Number: CS-15272-VFE
• Device Lot Number: 13F21H0134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2021
• 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: NOT REPORTED; NOT REPORTED