MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI CVC KIT: 3-L 7 FR X 8" (20 CM) AGB+; CATHETER,INTRAVASCULAR,THERAPE

Catalog Number	ASK-45703-PRJ
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that: the distal extention line of the cvc separated/tore mid line.It was located in the left ij and had been inserted 5 days previous.Patient condition is unknown, additional information has been requested from the account.
Event or Problem Description
It was reported that: the distal extention line of the cvc separated/tore mid line.It was located in the left ij and had been inserted 5 days previous.Patient condition is unknown.
Additional Manufacturer Narrative
(b)(4).Additional information received from the customer 23-oct-2023: "pt's line tubing required to be changed [been longer than 4 days], was supposed to be changed last night/yesterday.This writer was priming the lines and lines were changed.When this writer attempted to switch the lines over to the port, it was noted that the distal infusion port [brown] was broken, and the iv fluids were leaking.This writer called for assistance in a timely manner, and clamped the port to minimize risk of air embolism.Fortunately, this defected port was running with ringer's lactate only.Other sedation and pain medications were infusing via the other remaining ports with no issues.Md was informed, was rewired in a timely manner." it was also reported that no medical intervention was needed.The customer provided one photo showing a 3-lumen cvc for analysis.Visual analysis revealed that the distal extension line was severed.The customer returned one, 3-lumen cvc for analysis.Signs of use in the form of biological material were observed.Visual analysis revealed that the distal extension line was severed adjacent to the juncture hub.The point of separation was angled and smooth.Microscopic examination confirmed the damage and revealed that the edges were smooth and uniform and consistent with contact with a sharp instrument (i.E.Scissors, scalpel, etc.).The distal line was severed 10mm from the juncture hub.The distal extension line outer diameter measured 0.084", which is within the specification limits of 0.084"-0.088" per the distal extension line extrusion product drawing.The distal extension line inner diameter at the location of the separation measured 0.057", which is within the specification limits of 0.055"-0.059" per the distal extension line extrusion product drawing.The medial and proximal lines were flushed with a lab inventory syringe.No leaks or blockages were encountered.Performed per ifu statement, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)".A manual tug test confirmed that all extension line extrusions were secure within their 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 separation was confirmed through complaint investigation.Visual analysis revealed that the distal line was severed adjacent to the juncture hub.Further analysis revealed that the edges were smooth and uniform and consistent with contact with a sharp instrument (i.E.Scissors, scalpel, etc).Despite the damage, the catheter met all relevant dimensional and functional 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 sample received, 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.

• Brand Name: ARROW PI CVC KIT: 3-L 7 FR X 8" (20 CM) AGB+
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17974300
• Report Number: 9680794-2023-00814
• Device Sequence Number: 2491675
• Product Code: FOZ
• UDI-Device Identifier: 00801902098986
• UDI-Public: 00801902098986
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2023

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: 02/14/2025
• Device Catalogue Number: ASK-45703-PRJ
• Device Lot Number: 33F23C0569
• 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: 09/25/2023
• Supplement Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2023
• 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