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

Catalog Number	CDA-45703-XPCN1A
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the "blue port of 3-lumen cvad used for pressure injection at ct.Port marked "pressure injectable 5ml/sec".Post ct test, clear tubing from hub to splitter found to be distended, floppy".As a result, a new cvc was inserted.No patient harm or injury from the event.The patient status is reported as "critical".
Additional Manufacturer Narrative
(b)(4).The customer report of a stretched/ballooned extension line was confirmed through complaint investigation of the returned sample.The customer returned one 3-l cvc for evaluation.Signs-of-use were observed on the catheter body and inside the extension lines.Visual inspection revealed the medial extension line was stretched/ballooned down part of the extrusion.This damage appears consistent with unintentional over pressurization of the extension line during use.The stretching in the medial extension line was located 0-50mm via calibrated ruler from the luer hub.The extension line outer diameter (od) in a non-stretched location measured 0.0876" via calibrated caliper which was within the specifications of 0.084"-0.088" per product drawing.Functional inspection was performed per the product instructions for use which states "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." the medial extension line was flushed using a lab inventory 10ml syringe.Water exited out the catheter as expected.No leaks or blockages were observed.The instructions-for-use (ifu) provided with this kit warns the user, "precaution: do not exceed ten (10) injections or catheter's maximum recommended flow rate located on product labelling and catheter luer hub to minimize the risk of catheter failure and/or tip displacement.Precaution: pressure limit settings on injector equipment may not prevent over pressurizing an occluded or partially occluded catheter.Precaution: warm contrast media to body temperature prior to pressure injection to minimize the risk of catheter failure." the catheter met all relevant dimensional and functional requirements, and a device history record review based on a potential lot from sales history was performed with no relevant findings.Based on these circumstances, unintentional use error (overpressure) likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that the "blue port of 3-lumen cvad used for pressure injection at ct.Port marked "pressure injectable 5ml/sec".Post ct test, clear tubing from hub to splitter found to be distended, floppy".As a result, a new cvc was inserted.No patient harm or injury from the event.The patient status is reported as "critical".

• Brand Name: PI CVC KIT: 3-L 7 FR X 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 18402071
• Report Number: 9680794-2023-00992
• Device Sequence Number: 4209997
• Product Code: FOZ
• UDI-Device Identifier: 10801902162189
• UDI-Public: 10801902162189
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2023

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 Catalogue Number: CDA-45703-XPCN1A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2023
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 01/24/2024
• 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
• Patient Sex: Unknown