MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 12 FR X 16 CM; CATHETER PERCUTANEOUS

Model Number	IPN919472
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "the catheter was inserted on (b)(6) 2024.On 04 june, it began to malfunction, and a caretaker prescribed that the lines be reversed.On 06 june, as the malfunction appeared to be significant and pressure on the circuit was increasing, dialysis was stopped.When the catheter was tested again by the nurse, while aspirating, she "found and removed" some material that we did not identify.At first sight, it appears to be "inert" material, i.E.Plastic rather than a fibrin deposit as we had thought.We don't know where it came from.The patient did not experience any signs or symptoms because of this event.
Additional Manufacturer Narrative
(b)(4).The customer provided two photos for analysis.The photos show the foreign material the customer removed from the catheter.The customer also returned the foreign material for analysis.Signs of use were observed.Visual and microscopic analysis revealed the material appeared multicolored in nature.The sample was sent to material testing lab for ftir and sem testing of the foreign material.Based on visual and chemical characterization of the foreign material, data supports the foreign material to not be a catheter-related polymer used in the manufacturing process of the device.The customer report reveals the catheter was properly functioning within the patient for 6 days before signs of malfunctioning were detected.Two years of complaint history for finished goods with catheter mlb-32123-001 were reviewed, and there were no confirmed reports of foreign material inside the device.A device history record review was performed, and no relevant findings were identified.The instructions-for-use (ifu) provided with this kit warns the user, "ensure catheter patency prior to use.".The complaint of foreign material inside device was confirmed through complaint investigation of the returned sample.The customer reported the catheter to function properly for at least 6 days prior to the malfunction detected.In addition, material analysis of the foreign material suggests the foreign material is not a catheter related polymer used in the manufacturing process of the device.Based on the customer report, the sample received, and material analysis, the probable root cause cannot be determined.Teleflex will continue to monitor and trend on reports of this nature.
Event or Problem Description
It was reported that: "the catheter was inserted on (b)(6) 2024.On (b)(6), it began to malfunction, and a care taker prescribed that the lines be reversed.On (b)(6), as the malfunction appeared to be significant and pressure on the circuit was increasing, dialysis was stopped.When the catheter was tested again by the nurse, while aspirating, she "found and removed" some material that we did not identify.At first sight, it appears to be "inert" material, i.E.Plastic rather than a fibrin deposit as we had thought.We don't know where it came from.The patient did not experience any signs or symptoms because of this event.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: ARROW CVC SET: 3-LUMEN 12 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19728373
• Report Number: 3006425876-2024-00684
• Device Sequence Number: 12844015
• Product Code: DQY
• UDI-Device Identifier: 00801902102119
• UDI-Public: (01)00801902102119(11)230323(17)280229(10)71F23C1209(21)
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2024

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 Model Number: IPN919472
• Device Catalogue Number: CS-12123-F
• Device Lot Number: 71F23C1209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2024
• Supplement Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2023
• 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
• Patient Sex: Unknown