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

Catalog Number CDA-42703-XPCN1A

Device Problem Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/27/2023

Event Type  Injury  

Manufacturer Narrative

Qn# (b)(4).

Event Description

Customer complaint reports "central line inserted by physician and upon insertion the guide wire was lost in the right femoral vein.Vascular surgeon contacted for retrieval." additional information was requested but was not available at the time of this report.

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 a potentially relevant finding was identified.A non-conformance was initiated for batch 13c22k0191 to address the issue of a missing component.After further consideration of this non-conformance, it was determined that it is not relevant to this complaint.The ifu provided with the kit informs the user, "sufficient guidewire length must remain exposed at hub end of catheter to maintain a firm grip on guidewire".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 Description

Customer complaint reports "central line inserted by physician and upon insertion the guide wire was lost in the right femoral vein.Vascular surgeon contacted for retrieval." several attempts were made to get additional information regarding the event; however, the customer has not responded to the requests.

• Brand Name: ARROW PI CVC KIT: 3-L 7 FR X 16 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: 16544791
• MDR Text Key: 311302481
• Report Number: 9680794-2023-00234
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K071538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: CDA-42703-XPCN1A
• Device Lot Number: 13F22K0507
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/08/2023
• Initial Date FDA Received: 03/15/2023
• Supplement Dates Manufacturer Received: 04/27/2023
• Supplement Dates FDA Received: 05/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2022
• 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: NOT REPORTED.; NOT REPORTED.
• Patient Outcome(s): Required Intervention