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

Catalog Number	CDC-45703-XPN1A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "after the line with the brown cap was used for ct with contrast the line became flat.The icu team removed the central line and inserted a new one.There was no harm to the patient." no medical intervention required.The patient's current condition is reported as "fine".
Event or Problem Description
It was reported "after the line with the brown cap was used for ct with contrast the line became flat.The icu team removed the central line and inserted a new one.There was no harm to 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 evaluation.The report of an extension line stretched/ballooned was confirmed through inspection of the supplied photo.The photo shows a stretched/ballooned distal extension line.The customer also 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 distal extension line was stretched/ballooned partially down the extrusion.The observed damage appears consistent with unintentional over pressurization of the extension line during use.The stretched portion of the extension line measured 0-70mm from the luer hub.The distal extension line outer diameter in a non-stretched area measured 0.08564" which is within the specifications of 0.084"-0.088" per product drawing.The distal extension line inner diameter could not be accurately measured due to the damage.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 distal extension line was flushed using a lab inventory 10ml syringe.Water exited out the catheter as expected.No leaks or blockages were observed.A device history record review was performed with no relevant findings.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 labeling 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 customer report of a stretched/ballooned extension line was confirmed through complaint investigation of the returned sample.Visual inspection revealed the distal extension line was partially stretched/ballooned.The observed damage is consistent with over pressurization of the extension line during use.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.

• Brand Name: ARROW 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18748218
• Report Number: 9680794-2024-00156
• Device Sequence Number: 19792757
• Product Code: FOZ
• UDI-Device Identifier: 10801902162042
• UDI-Public: 10801902162042
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2024

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
• Device Expiration Date: 09/30/2024
• Device Catalogue Number: CDC-45703-XPN1A
• Device Lot Number: 33F23F0508
• 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: 02/01/2024
• Supplement Date Received by Manufacturer: 03/21/2024
• Initial Report FDA Received Date: 02/21/2024
• Supplement Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2023
• 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: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown