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-XP1A

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/28/2024

Event Type  malfunction  

Event Description

It was reported " during insertion the wire had difficulty advancing past the needle tip.Once the wire was withdrawn it had kinked that would not advance." it was orginally reported there was no patient injury or consequence.No medical intervention required and the patient's current condition is reported as "fine".Additional information receieved said the patient's current condition is "expired".It is reported as "unknown" if the malfunction contributed to the patient's death as the patient was 92 with respiratorg issues.Associated mdr numbers : 9680794-2024-00304, 9680794-2024-00306, and 9680794-2024-00307.

Manufacturer Narrative

Qn#(b)(4).

Event Description

It was reported " during insertion the wire had difficulty advancing past the needle tip.Once the wire was withdrawn it had kinked that would not advance." it was orginally reported there was no patient injury or consequence.No medical intervention required and the patient's current condition is reported as "fine".Additional information receieved said the patient's current condition is "expired".It is reported as "unknown" if the malfunction contributed to the patient's death as the patient was 92 with respiratorg issues.Associated mdr numbers : 9680794-2024-00304, 9680794-2024-00306, and 9680794-2024-00307.

Manufacturer Narrative

Qn#(b)(4) 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 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.

• Brand Name: ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB
• Type of Device: 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: 19018628
• MDR Text Key: 339247120
• Report Number: 9680794-2024-00305
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 20801902117216
• UDI-Public: 20801902117216
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/08/2024

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 Catalogue Number: CDC-45703-XP1A
• Device Lot Number: 33F23F0056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 04/02/2024
• Supplement Dates Manufacturer Received: 04/22/2024
• Supplement Dates FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED