MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 7FR X 20CM; CATHETER, PERCUTANEOUS

Model Number	IPN918690
Medical Device Problem Codes	Gas/Air Leak (2946); Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "they experience that ars is not "sealed" properly at the connection of needle and syringe and that ars sucks in the air when used.There was no reported patient complications.
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that "they experience that ars is not "sealed" properly at the connection of needle and syringe and that ars sucks in the air when used.There was no reported patient complications.Associated complaints (b)(4).
Additional Manufacturer Narrative
(b)(4).The complaint of faulty syringe/needle connection was not able to be confirmed by a complaint investigation of the returned samples.The customer returned one arrow raulerson syringe (ars) and an 18ga introducer needle.Signs-of-use in the form of biological material were observed inside the needle hub.Visual inspection of the introducer needle and ars did not reveal any defects or anomalies.The tip of the ars syringe was compared to a lab inventory ars and no differences were noted.The connection between the returned syringe and needle was compared with another ars syringe and introducer needle from lab inventory.The returned ars syringe was tested with a lab inventory needle, and the returned needle was tested with a lab inventory ars syringe.The returned needle appears to be fitting securely on both the returned syringe and the lab inventory syringe.The hub of the needle was tested with the male luer gauge and was within the specified range.This indicates that the luer was conforming per iso.The instructions for use (ifu) provided with this kit informs the user, "insert introducer needle or catheter/needle with attached syringe or arrow raulerson syringe (where provided) into vein and aspirate".A device history record review was performed, and no relevant findings were identified.Based on the customer report and the sample returned, no problem was found with the returned sample.Teleflex will continue to monitor and trend on complaints of this nature.
Additional Manufacturer Narrative
(b)(4).In section d provided the full udi # **udi related data quality updates only** other remarks: n/a, corrected data: n/a.
Event or Problem Description
It was reported that "they experience that ars is not "sealed" properly at the connection of needle and syringe and that ars sucks in the air when used.There was no reported patient complications.Associated complaints 3006425876-2023-01237 and 3006425876-2023-01236.

• Brand Name: ARROW CVC SET: 2-LUMEN 7FR X 20CM
• 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: laura guadalupe gonzalez ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18316849
• Report Number: 3006425876-2023-01236
• Device Sequence Number: 6718240
• Product Code: DQY
• UDI-Device Identifier: 10801902156867
• UDI-Public: (01)10801902156867(11)220915(17)270831(10)71F22J0712(21)
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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): 11/16/2023

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
• Operator of Device: Health Professional
• Device Model Number: IPN918690
• Device Catalogue Number: CV-16702-E
• Device Lot Number: 71F22J0712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2023
• Supplement Date Received by Manufacturer: 01/03/2024; Not provided
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 01/08/2024; 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2022
• 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