MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 5.5 FR X 13 CM; CATHETER PERCUTANEOUS

Catalog Number	CS-16553-E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that (b)(6) 2023, the catheter was found to be leaking during use on the patient.
Event or Problem Description
It was reported that"09 nov 2023, the catheter was found to be leaking during use on the patient.
Additional Manufacturer Narrative
Qn# (b)(4).The customer report of a leaking catheter was confirmed by visual inspection of the customer supplied video.The video shows a catheter in a clincal setting being flushed and a leak can be observed from the catheter body, however, full complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Additional Manufacturer Narrative
(b)(4).The customer returned one, 3-lumen cvc for evaluation.Signs of use were observed on the catheter body.Visual inspection of the catheter revealed a hole in the catheter body extrusion.The edges appeared smooth which is consistent with contact with a sharp object during use.The hole in the catheter body extrusion was located 66 mm from the juncture hub.The catheter body length measured 5 7/16" which is within the specifications of 5 1/4"-5 3/4" per catheter product drawing.The catheter body outer diameter measured 0.07230" which is within the specifications of 0.0690"-0.0740" per catheter body extrusion product drawing.Functional inspection of the catheter was performed per ifu statement, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." water leaked out of the hole in the catheter while flushing the distal and medial extension lines.No leaks were observed when flushing the proximal line.A device history record review was performed and no relevant findings were identified.The ifu provided with the kit informs the user, "do not secure, staple and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations".The report of a catheter leak was confirmed through complaint investigation.Visual analysis revealed a hole on the catheter body.During functional analysis, leaking was observed from this hole when flushing the distal and medial extension lines.The edges of the hole were smooth and appear consistent with damage due to contact with a sharp instrument (i.E.Scalpel, scissors, etc.).Despite the damage, the catheter met all relevant dimensional requirements, and a device history record review did not reveal any relevant findings.Based on the customer report that the damage was observed during use and the appearance of the damage , unintentional use error (contact with sharps) 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"on (b)(6) 2023, the catheter was found to be leaking during use on the patient.
Additional Manufacturer Narrative
(b)(4).In section d provided the full udi #.Udi related data quality updates only.
Event or Problem Description
It was reported that" (b)(6) 2023, the catheter was found to be leaking during use on the patient.

• Brand Name: ARROW CVC SET: 3-LUMEN 5.5 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: 18265498
• Report Number: 3006425876-2023-01158
• Device Sequence Number: 3890597
• Product Code: DQY
• UDI-Device Identifier: 30801931122981
• UDI-Public: (01)30801931122981(11)220211(17)251031(10)71F22B0654(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 11/09/2023

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 Expiration Date: 10/31/2025
• Device Catalogue Number: CS-16553-E
• Device Lot Number: 71F22B0654
• 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: 11/09/2023
• Supplement Date Received by Manufacturer: 12/20/2023; 04/26/2024; Not provided
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 12/20/2023; 04/29/2024; 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2022
• 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; NOT REPORTED
• Patient Sex: Unknown