MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC HEMODIALYSIS SET: 2-LUMEN 12 FR X 25 CM; CATHETER PERCUTENEOUS

Model Number	IPN919963
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: hemodialysis catheter inserted under ultrasound guidance into the right femoral vein.During cannulation, they used an introducer needle.Inserted swg after syringe disconnection.The catheter is placed along the swg.As the swg is removed through the catheter.There is resistance.The swg was pulled out with force (being careful not to damage the vessel).The end of the guide takes the shape of a "pig's tail", a "coiled spring".Clinical consequences: the catheter is blocked after this.This catheter must be removed and the hemodialysis catheter placed elsewhere.This situation occurred three times in the ward.3 different operators, 3 different patients.Photos attached showed that the catheter was bent.Associated complaints (b)(4).
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer report of kinked catheter was confirmed by visual inspection of the customer supplied photo.Biomaterial was additionally observed at the location of the kink within the catheter.However, full complaint verification testing to evaluate the cause of the damage could not be performed as no sample was returned for analysis.The instructions for use (ifu) provided with this kit warns the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage." a device history record review was performed, and no relevant findings were identified.Without the device to evaluate, 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
It was reported that: hemodialysis catheter inserted under ultrasound guidance into the right femoral vein.During cannulation, they used an introducer needle.Inserted swg after syringe disconnection.The catheter is placed along the swg.As the swg is removed through the catheter.There is resistance.The swg was pulled out with force (being careful not to damage the vessel).The end of the guide takes the shape of a "pig's tail", a "coiled spring".Clinical consequences: the catheter is blocked after this.This catheter must be removed and the hemodialysis catheter placed elsewhere.This situation occurred three times in the ward.3 different operators, 3 different patients.Photos attached showed that the catheter was bent.Associated complaints 3006425876-2023-01206, 3006425876-2023-01207, 3006425876-2023-01205, and 3006425876-2024-00021.

• Brand Name: HEMODIALYSIS SET: 2-LUMEN 12 FR X 25 CM
• Common Device Name: CATHETER PERCUTENEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18442166
• Report Number: 3006425876-2024-00020
• Device Sequence Number: 12495099
• Product Code: DQY
• UDI-Device Identifier: 10801902096583
• UDI-Public: 10801902096583
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 01/01/2024

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: 01/13/2025
• Device Model Number: IPN919963
• Device Catalogue Number: CS-26122-F
• Device Lot Number: 71F23F0936
• 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: 01/01/2024
• Supplement Date Received by Manufacturer: 03/22/2024
• Initial Report FDA Received Date: 01/04/2024
• Supplement Report FDA Received Date: 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2023
• 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
• Patient Sex: Female