MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CVC SET: 4-LUMEN 8.5FR X 16CM; CATHETER, PERCUTANEOUS

Model Number	IPN918726
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported "during one of the night rounds, the caregiver found the patient with a cvc (central venous catheter) with one of the 4 lines cut off at the cuff.The proximal line had lost its white sleeve.The line was immediately clamped.Later the cvc was removed and a new cvc inserted." it was reported the patient had no adverse effects or consequence.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer returned one, four-lumen cvc for analysis.Signs of use in the form of biological material were observed inside the extension line.Visual analysis revealed that the distal and proximal extension lines were severed directly adjacent to the luer hubs.Remains of both extension lines were visible within the respective luer hubs.Microscopic examination confirmed the damage and revealed that both points of separation were rough/jagged.The catheter body measured 170mm, which is within the specification limits of 157mm-177mm per catheter product drawing.The distal extension line outer diameter measured 2.16mm which is within the specification limits of 2.13-2.21mm per the distal extension line extrusion product drawing.The distal extension line inner diameter measured 1.4478mm, which is within the specification of 1.42mm-1.50mm per the distal extension line extrusion product drawing.The proximal extension line outer diameter measured 2.16mm which is within the specification limits of 2.13-2.21mm per proximal extension line extrusion product drawing.The proximal extension line inner diameter measured 1.4478mm, which is within the specification of 1.42-1.50mm per proximal extension line extrusion product drawing.Functional inspection of the catheter was performed per the product ifu, which instructs the user, "check lumen patency by attaching a syringe to each extension line and aspirate until free flow of venous blood is observed".The medial1 and medial2 extension lines were flushed using a lab inventory arrow raulerson syringe (ars) syringe.The extension lines flushed as intended.A manual tug test confirmed the medial1 and medial2 extension lines were fully secured to the respective luer hubs.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 an extension line/luer hub separation was confirmed through complaint investigation.Visual analysis revealed that the proximal and distal extension lines had separated adjacent to the respective luer hubs.It was noted that remains of each extension line were found within the respective luer hubs.A capa has previously been initiated due to an increasing trend of cvc extension line leaks and separations.The capa investigation indicated the root cause of this issue is manufacturing related.Corrective actions have not yet been implemented.Teleflex will continue to monitor and trend complaints of this nature.
Event or Problem Description
It was reported "during one of the night rounds, the caregiver found the patient with a cvc (central venous catheter) with one of the 4 lines cut off at the cuff.The proximal line had lost its white sleeve.The line was immediately clamped.Later the cvc was removed and a new cvc inserted." it was reported the patient had no adverse effects or consequence.The patient's condition is reported as fine.

• Brand Name: CVC SET: 4-LUMEN 8.5FR X 16CM
• 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: 15956313
• Report Number: 3006425876-2022-01074
• Device Sequence Number: 12402577
• Product Code: DQY
• UDI-Device Identifier: 00801902029232
• UDI-Public: 00801902029232
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 11/16/2022

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: 05/31/2026
• Device Model Number: IPN918726
• Device Catalogue Number: CV-12854
• Device Lot Number: 71F22A2708
• 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: 11/16/2022
• Supplement Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 12/11/2022
• Supplement Report FDA Received Date: 01/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2022
• 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.
• Patient Sex: Unknown