MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 5.5 FR X 8 CM; CATHETER PERCUTANEOUS

Model Number	IPN918853
Medical Device Problem Codes	Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported " a pediatric cvc was dfficult to inserted into the needle.The guide appeared to stall and unravelled when removed.The needle associated with the guide had to be removed." a new guide was inserted.No medical intervention required.The patient's current condition is reported as "stable".
Additional Manufacturer Narrative
(b)(4).The customer returned one, opened cvc kit for analysis.No obvious signs of use were observed on the guide wire.It was noted that the introducer needle involved with this complaint was not returned.Visual analysis revealed that the guide wire was kinked towards the distal end.The kinking resulted in the distal j-bend to be slightly misshapen.Microscopic examination confirmed the damage and revealed that the distal and proximal welds were secure and intact.Visual analysis could not be performed on the introducer needle involved with this complaint as it was not returned.The kinks in the guide wire were located 433mm from the proximal tip.The overall length of the guide wire measured 456mm, which is within the specification of 449.2mm-458mm per the guide wire product drawing.The outer diameter of the guide wire measured 0.440mm, which is within the specification of 0.432mm-0.457mm per guide wire product drawing.Dimensional analysis could not be performed on the introducer needle involved with this complaint as it was not returned.The returned guide wire was inserted through a lab inventory 21ga introducer needle.Resistance was encountered at the location of the kinking; however, all functional sections of the guide wire passed with little to no difficulty.Performed per ifu statement, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle".Functional analysis could not be performed on the introducer needle involved with this complaint as it was not returned.A manual tug test on the guide wire confirmed that the distal and proximal welds are secure and intact.A device history record review was performed on the guide wire, and a finding was identified; however, it could not be confirmed if the finding was relevant.The ifu provided with the kit informs the user, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage".The report that the guide wire kinked during use was confirmed through examination of the returned sample.The guide wire was kinked towards the distal j-bend.The returned guide wire met all relevant dimensional and functional requirements.Despite the damage, without the introducer needle involved with this complaint also returned for analysis, the root cause cannot be determined at this time.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported " a pediatric cvc was dfficult to inserted into the needle.The guide appeared to stall and unravelled when removed.The needle associated with the guide had to be removed." a new guide was inserted.No medical intervention required.The patient's current condition is reported as "stable".

• Brand Name: ARROW CVC SET: 3-LUMEN 5.5 FR X 8 CM
• Common Device Name: CATHETER PERCUTANEOUS
• 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: 18838343
• Report Number: 3006425876-2024-00163
• Device Sequence Number: 18006704
• Product Code: DQY
• UDI-Device Identifier: 30801929122979
• UDI-Public: 30801929122979
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2024

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 Model Number: IPN918853
• Device Catalogue Number: CS-15553-E
• Device Lot Number: 71F22C1665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2024
• Supplement Date Received by Manufacturer: 03/05/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2022
• 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: NONE REPORTED.; NONE REPORTED.
• Patient Age: 24 MO
• Patient Sex: Unknown