MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC KIT: 2-LUMEN 4 FR X 8 CM; CATHETER INTRAVASCULAR THERAPE

Model Number	IPN916994
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "i was first contacted about a dilator issue in the small vein cvc kits by a clinical resource director in an email on 3/2.She did not have any information about the complaint, so she connected me to the end users.It took a while to get in touch with these end users (mds in the picu) and yesterday 3/13 was the first available date they could meet to discuss the details of the dilator issues.The mds in the picu have been experiencing repeated dilator issues in the small vein cvc kits.They report that the dilator is soft and bends at or near the tip, making it difficult to advance the guidewire or kinking the guidewire as a result.They also reported that the dilator frays.They told me that this has been happening for some time, and that it requires them to often open another kit to use a second dilator." additional information received stated that four kits were used, all four devices were bending or freying.All four devices were used on different patients there was no injury or harm.No medical intervention was required.All four patient conditions are reported to be "fine".There was a delay in therapy as they had to retrieve and open another kit for a new dilator.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn# (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.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.
Event or Problem Description
It was reported "i was first contacted about a dilator issue in the small vein cvc kits by a clinical resource director in an email on (b)(6) 2023.She did not have any information about the complaint, so she connected me to the end users.It took a while to get in touch with these end users (mds in the picu) and yesterday (b)(6) 2023 was the first available date they could meet to discuss the details of the dilator issues.The mds in the picu have been experiencing repeated dilator issues in the small vein cvc kits.They report that the dilator is soft and bends at or near the tip, making it difficult to advance the guidewire or kinking the guidewire as a result.They also reported that the dilator frays.They told me that this has been happening for some time, and that it requires them to often open another kit to use a second dilator." additional information received stated that four kits were used, all four devices were bending or freying.All four devices were used on different patients there was no injury or harm.No medical intervention was requi red.All four patient conditions are reported to be "fine".There was a delay in therapy as they had to retrieve and open another kit for a new dilator.

• Brand Name: ARROW CVC KIT: 2-LUMEN 4 FR X 8 CM
• 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: 16700647
• Report Number: 9680794-2023-00263
• Device Sequence Number: 5821650
• Product Code: FOZ
• UDI-Device Identifier: 10801902167795
• UDI-Public: 10801902167795
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K900263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2023

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 Model Number: IPN916994
• Device Catalogue Number: AK-25402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2023
• Supplement Date Received by Manufacturer: 05/02/2023
• Initial Report FDA Received Date: 04/07/2023
• Supplement Report FDA Received Date: 05/02/2023
• 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