MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2L 5 FR X 13 CM; CATHETER PERCUTANEOUS

Catalog Number	CS-14502
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: (b)(6) 2023, the ars was found leaking during used on the patient.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one, opened cvc kit for analysis.No definite signs of use in the form of biomaterial were observed on any of the returned components.Visual analysis of the syringe revealed no obvious defects or anomalies.The msk graphic for the finished good ((b)(6) rev72) was reviewed.The returned syringe matches what is pictured.The 5ml syringe was functionally tested per the instructions for use (ifu) provided with this kit, which instructs the user, "insert introducer needle or catheter/needle with attached syringe or arrow raulerson syringe (where provided) into vein and aspirate".The syringe was connected to the returned catheter over needle and was able to draw and aspirate water as intended.The module requirement document for standard syringes ((b)(4) rev 07) was reviewed to determine requirements for air/water leakage.Section 7.3 outlines the performance testing for air/water leakage, which states, "when tested in accordance to annex d of bs en iso 7886-1, there shall be no leakage of water past the plunger stopper or seal(s).Small droplets between the seals are not considered failure".With the plunger body at the bottom of the syringe, the tip of the syringe was occluded, and the plunger was pulled back until it stopped.With the tip of the syringe still occluded, the plunger was released and did snap back into a position = 1cc from the starting position.No air leaks past the plunger stopper.Likewise, the plunger stopper did not become detached from the plunger.A device history record review was performed, and a potentially relevant finding was identified.A non-conformance was initiated to address the issue of "product does not correspond to the drawing".However, based on the returned sample, it has been concluded that this is not relevant to this investigation.The msk product drawing of the reported finished good.It is confirmed that the returned syringe matches what is pictured.The ifu provided with the kit informs the user, "ensure catheter patency prior to use.Do not use syringes smaller than 10 ml (a fluid filled 1 ml syringe can exceed 300 psi) to reduce risk of intraluminal leakage or catheter rupture".The customer report of a leaking injection syringe could not be confirmed through investigation of the returned sample.The syringe passed all relevant functional testing when tested in accordance with annex d of bs en iso 7886-1.Based on the customer description and sample received, no problem was found.Teleflex will continue to monitor and trend on reports of this nature.
Event or Problem Description
It was reported that: (b)(6) 2023, the ars was found leaking during used on the patient.
Event or Problem Description
It was reported that: (b)(6) 2023, the ars was found leaking during used on the patient.
Additional Manufacturer Narrative
(b)(4).In section d provided the full udi #.Udi related data quality updates only.

• Brand Name: ARROW CVC SET: 2L 5 FR X 13 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: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18299531
• Report Number: 3006425876-2023-01211
• Device Sequence Number: 3225413
• Product Code: DQY
• UDI-Device Identifier: 30801921122939
• UDI-Public: (01)30801921122939(11)221003(17)270930(10)71F22J3111(21)
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 11/14/2023

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
• Device Catalogue Number: CS-14502
• Device Lot Number: 71F22J3111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2023
• Supplement Date Received by Manufacturer: 01/03/2024; Not provided
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 01/04/2024; 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2022
• 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: NOT REPORTED; NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown