MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8" (2; CATHETER,INTRAVASCULAR,THERAPE

Model Number	IPN037072
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reports it took three attempts to place a central line in the patient.On the first attempt in left femoral vein, the wire was placed and while attempting to dilate, the wire bent and became malformed.The catheter would not pass over the wire.Procedure was aborted and second attempt made in right ij.When attempting to thread the second wire it kinked and would not advance through the needle.Procedure aborted and third attempt made in right femoral.The third wire kinked while advancing the catheter and became stuck within the catheter.When trying to remove the wire from the catheter, the wire frayed.The wire was able to be removed and the user was able to draw blood from and flush all ports.No patient injury was reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
Customer reports it took three attempts to place a central line in the patient.On the first attempt in left femoral vein, the wire was placed and while attempting to dilate, the wire bent and became malformed.The catheter would not pass over the wire.Procedure was aborted and second attempt made in right ij.When attempting to thread the second wire it kinked and would not advance through the needle.Procedure aborted and third attempt made in right femoral.The third wire kinked while advancing the catheter and became stuck within the catheter.When trying to remove the wire from the catheter, the wire frayed.The wire was able to be removed and the user was able to draw blood from and flush all ports.No patient injury was reported.The patient's condition is reported as fine.

• Brand Name: ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8" (2
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• 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: 13095445
• Report Number: 9680794-2021-00691
• Device Sequence Number: 2008141
• Product Code: FOZ
• UDI-Device Identifier: 30801902119644
• UDI-Public: 30801902119644
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 12/08/2021

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: 06/30/2023
• Device Model Number: IPN037072
• Device Catalogue Number: ASK-45703-AKP1A
• Device Lot Number: 13F21H1178
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2021
• Supplement Date Received by Manufacturer: 01/21/2022
• Initial Report FDA Received Date: 12/28/2021
• Supplement Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2021
• 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
• Patient Sex: Unknown