MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 4-LUMEN 8.5FR X 20CM; CATHETER, PERCUTANEOUS

Model Number	IPN030893
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	High Blood Pressure/ Hypertension (1908)
Date of Event	06/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported the nurse found the sedation access of the central line proximal to the catheter was leaking.It was reported it was unknown how long the access had been punctured, but the patient had been unexpectedly hypertensive for the last few days.A new catheter was placed.No patient injury was reported.The patient's condition was reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer returned one 4-l cvc catheter for evaluation.Signs of use in the form of biological material were noted in the extension lines.Visual inspection of the catheter revealed a cut in the medial 2 (blue luer hub) line.The cut appeared smooth , consistent with contact with sharps such as a scalpel or needle.The total length of the catheter measured 225 mm, which is within specifications of 207-227 mm per catheter graphic.The cut in the medial 2 extension line measured 77 mm from the luer hub.The outer diameter of the medial 2 extension line measured 2.171 mm, which is between 2.13-2.21 mm per medial 2 extrusion graphic.The inner diameter of the medial 2 extension line measured 1.4224 mm which is between 1.42-1.50 mm per medial 2 extrusion graphic.The catheter was functionally tested per the instructions for use (ifu).The ifu provided with this kit states, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." each lumen was flushed with a lab syringe filled with water.When the medial 2 line was flushed water leaked from the cut in the extension line.The distal, medial 1, and proximal lines flushed as expected.A manual tug test confirmed all four luer hubs were secure.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit warns 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 complaint of an extension line leaking was confirmed by a complaint investigation of the returned sample.Functional testing revealed that the medial 2 extension line had a cut in it.A device history record review was performed, and no relevant findings were identified.Based on the customer description and the nature of the damage observed to the extension line, unintentional use error - contact with sharps likely caused or contributed to this event.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported the nurse found the sedation access of the central line proximal to the catheter was leaking.It was reported it was unknown how long the access had been punctured, but the patient had been unexpectedly hypertensive for the last few days.A new catheter was placed.No patient injury was reported.The patient's condition was reported as fine.

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5FR X 20CM
• 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: 14804533
• Report Number: 3006425876-2022-00570
• Device Sequence Number: 17296425
• Product Code: DQY
• UDI-Device Identifier: 10801902029291
• UDI-Public: 10801902029291
• 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): 06/08/2022

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: 11/30/2025
• Device Model Number: IPN030893
• Device Catalogue Number: CV-15854
• Device Lot Number: 71F21E0431
• 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: 06/08/2022
• Supplement Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 06/24/2022
• Supplement Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2021
• 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