MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 16 CM; CATHETER PERCUTANEOUS

Catalog Number	CV-12703
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "the proximal line bent." there was no clinical consequences for the patient.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4) the customer provided one photo for analysis.The photo shows the medial extension line with what appears to be a kink near the juncture hub.The customer returned one, 3-lumen catheter for analysis.Signs of use were observed.The catheter body was observed to have been intentionally severed.Visual analysis of the returned catheter revealed no signs of a kink were observed on the proximal extension line nor the medial extension line despite what was observed in the customer provided pho-to.Evidence of use (dried blood) was observed within the extension line lumens; however, no defects, anomalies, or evidence of previous kinking was observed.The outer diameter (od) of the medial ex-tension line measured 2.14 mm, which is within the specification limits of 2.13-2.21 mm per medial extension line extrusion drawing.The inner diameter (id) of the medial extension line measured 0.059", or 1.49 mm, which is within the specification limits of 1.42-1.50 mm per medial extension line extrusion drawing.The od of the proximal extension line measured 2.16 mm, which is within the specification limits of 2.13-2.21 mm per proximal extension line extrusion drawing.The id of the me-dial extension line measured 0.059", or 1.49 mm, which is within the specification limits of 1.42-1.50 mm per proximal extension line extrusion drawing.The catheter was functionally tested per the product instructions-for-use (ifu).The ifu provided with this kit instructs the user, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." a lab inventory filled with water was used to flush each extension line.No signs of a blockage were observed, and each lumen flushed as expected during lab testing.A manual tug test confirmed that the extension lines were secure within their respective luer hubs.A device history record review was performed based on a potential lot from sales history, and no relevant findings were identified.The ifu provided with this kit informs the user, "minimize catheter manipulation throughout procedure to maintain proper catheter tip position.Do not alter the catheter, guidewire or any other kit/set component during insertion, use or removal." the customer report of an extension line kink was confirmed based on review of the customer photo; however, visual, and functional inspections of the returned catheter did not reveal any defects or anomalies with either of the three extension lines.The catheter met all relevant dimensional and functional requirements and a device history record review performed based on a potential lot from sales history identified no relevant findings.Based on the customer report and the returned sample, the root cause cannot be determined as no kink was observed on the returned sample de-spite one shown in the customer photo, and it is unknown whether unintentional catheter manipulation or patient movement may have contributed to the obstruction in the extension line.Teleflex will continue to monitor and trend on reports of this nature.Corrected data: udi number unavailable as complainant did not report a lot number.
Event or Problem Description
It was reported "the proximal line bent." there was no clinical consequences for the patient.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 16 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19461723
• Report Number: 3006425876-2024-00562
• Device Sequence Number: 6734940
• Product Code: DQY
• UDI-Device Identifier: 10801902105223
• UDI-Public: 10801902105223
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2024

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 Catalogue Number: CV-12703
• Device Lot Number: UNKNOWN
• 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: 05/10/2024
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown