MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI CVC KIT: 3-L 7 FR X 16 CM AGB; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CDC-42703-XP1A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Medwatch report received: "on (b)(6) 2023 this patient had a 20cm left subclavian cvc placed by ir.It functioned properly, until (b)(6) 2023 when rn heard a little pop and saw that the distal lumen had come off at the plastic brown part and blood was leaking out.Rn clamped line and tied a knot in the lumen.Md contacted and central line was removed.Ref report: mw5120620." no patient harm was reported.The cvc was removed and a new one placed.The patient's condition is reported as "stable".
Additional Manufacturer Narrative
(b)(4).Medwatch report # mw5120619.
Event or Problem Description
Medwatch report received: "on (b)(6) 2023 this patient had a 20cm left subclavian cvc placed by ir.It functioned properly, until (b)(6) 2023 when rn heard a little pop and saw that the distal lumen had come off at the plastic brown part and blood was leaking out.Rn clamped line and tied a knot in the lumen.Md contacted and central line was removed.Ref report: mw5120620." no patient harm was reported.The cvc was removed and a new one placed.The patient's condition is reported as "stable".
Additional Manufacturer Narrative
(b)(4).Medwatch report # mw5120619.Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed based on a potential lot taken from the sales history of the customer, and there was one potential finding.Without the sample returned, it cannot be confirmed if the failure mode of this complaint is relevant to the finding.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW PI CVC KIT: 3-L 7 FR X 16 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: 17809843
• Report Number: 9680794-2023-00697
• Device Sequence Number: 20506252
• Product Code: FOZ
• UDI-Device Identifier: 10801902117080
• UDI-Public: 10801902117080
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2023

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: CDC-42703-XP1A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2023
• Supplement Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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