MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7FR X 20CM; CATHETER, PERCUTANEOUS

Model Number	IPN918688
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	11/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: they experienced that ars is not "sealed" properly at the connection of needle and syringe and that ars sucks in the air when used.The issue was identified during use but there was no reported patient harm or intervention needed.Associated complaints 3006425876-2023-01227, 3006425876-2023-01229 and 3006425876-2023-01230.
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 sample.The customer returned one arrow raulerson syringe (ars) for analysis.The introducer needle involved with this complaint was not returned.No definite signs of use were observed.Visual inspection of the ars did not reveal any defects or anomalies.Visual analysis could not be performed on the introducer needle as it was not returned for analysis.The tip of the ars syringe was compared to a lab inventory ars and no differences were noted.The returned ars syringe was tested with a lab inventory needle.The connection appears to be secure.Additional testing could not be performed on the introducer needle involved with this complaint as it was not returned for analysis.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 received, the root cause could not be determined at this time.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported that: they experienced that ars is not "sealed" properly at the connection of needle and syringe and that ars sucks in the air when used.The issue was identified during use but there was no reported patient harm or intervention needed.Associated complaints 3006425876-2023-01227, 3006425876-2023-01228, 3006425876-2023-01229 and 3006425876-2023-01230.
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 experienced that ars is not "sealed" properly at the connection of needle and syringe and that ars sucks in the air when used.The issue was identified during use but there was no reported patient harm or intervention needed.Associated complaints 3006425876-2023-01227, 3006425876-2023-01228, 3006425876-2023-01229 and 3006425876-2023-01230.

• Brand Name: ARROW CVC SET: 3-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: 18309255
• Report Number: 3006425876-2023-01228
• Device Sequence Number: 17671018
• Product Code: DQY
• UDI-Device Identifier: 00801902000606
• UDI-Public: (01)00801902000606(11)220609(17)270531(10)71F22F1685(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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/15/2023

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: IPN918688
• Device Catalogue Number: CV-15703-E
• Device Lot Number: 71F22F1685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2023
• Supplement Date Received by Manufacturer: 01/03/2024; Not provided
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 01/05/2024; 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2022
• 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