MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CVC SET: 2-LUMEN 8 FR X 20 CM; CATHETER,INTRAVASCULAR,THERAP

Catalog Number	CS-25802-E
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that " swg resistance/hard to advance.No adverse reaction occurred in a patient." the returned device was kinked.
Additional Manufacturer Narrative
(b)(4).The customer returned one, opened cvc kit including one guide wire and its advancer, an arrow raulerson syringe (ars), and an 18ga introducer needle for analysis.Signs of use were observed on the returned components.Visual analysis revealed the guide wire was not within its advancer but was advanced through the ars/introducer needle assembly.The needle cannula appeared bent.The guide wire was removed from the introducer needle/ars assembly and was observed to have three kinks on the body.Excess biological material was observed on the guide wire portion that was within the needle cannula.The distal j-bend was not misshapen and was intact.Both welds were present and were observed to be full and spherical.No defects or anomalies were on the ars.The kinks in the guide wire measured 320 mm, 385 mm, and 388 mm from the proximal tip.The overall length of the guide wire measured 601 mm, which is within the specification limits of 596-604 mm per guide wire product drawing.The outer diameter of the guide wire measured 0.801 mm, which is within the specification limits of 0.788-0.826 mm per guide wire product drawing.The outer diameter of the needle cannula measured 0.0499" which is within the specification limits of 0.0495"-0.0505" per needle cannula product drawing.The inner diameter of the needle cannula measured 0.041" which is within the specification limits of 0.041"-0.043" per needle cannula product drawing.The guide wire was removed from the ars/introducer needle assembly for functional testing.The guide wire and introducer needle were functionally tested per the product instructions-for-use (ifu).The ifu provided with this kit instructs the user, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." the guide wire was advanced through the returned ars and 18ga introducer needle.The undamaged portions of the guide wire passed through both components with little to no resistance.A manual tug test confirmed that both the distal and proximal welds were intact.A device history record review was performed, and no relevant manufacturing issues were identified.The ifu provided with the kit informs the user, "advancement of guidewire through arrow raulerson syringe may require a gentle twisting motion.Do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage.".The report of a guide wire/needle resistance with a kinked guide wire was confirmed through complaint investigation of the returned sample.Three kinks were observed on the returned guide wire and the needle cannula appeared bent.Since the customer reported the resistance during use, this suggests the excess biological material resulted in the use of undue force resulting in both the kinking in the guide wire and bending in the needle.The returned guide wire and introducer needle met all relevant dimensional and functional requirements.A device history record review did not identify any manufacturing related issues.Based on the customer report and the sample received, unintentional use error along with needle blockage due to biological material likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that " swg resistance/hard to advance.No adverse reaction occurred in a patient." the returned device was kinked.

• Brand Name: CVC SET: 2-LUMEN 8 FR X 20 CM
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19220900
• Report Number: 3006425876-2024-00507
• Device Sequence Number: 8193941
• Product Code: FOZ
• UDI-Device Identifier: 00801902102331
• UDI-Public: 00801902102331
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K900263
• 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): 04/29/2024

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: 12/31/2024
• Device Catalogue Number: CS-25802-E
• Device Lot Number: 71F23A1151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2024
• Supplement Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2023
• 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: Unknown