MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC PI CVC KIT: 3L 7 FR X 20 CM AGB+; CATHETER,INTRAVASCULAR,THERAPE

Catalog Number ASK-45703-PNHS1

Device Problem Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/24/2023

Event Type  Injury  

Manufacturer Narrative

Qn#(b)(4).N/a other remarks: n/a corrected data: n/a.

Event Description

It was reported that "our facility placed a 20 cm central venous catheter on a patient (b)(6) 2023.While passing the wire, the patient jerked, and the wire bent.While sliding the wire out, the atraumatic tip frayed and broke off leaving a piece of the wire partially in the vein, but also within the soft tissues.The patient was taken to surgery to have it removed".No patient harm or injury.The patient status is reported as "stable".

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review could not be performed as no lot number was provided and a potential lot could not be identified based on a sales history review for this customer.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.Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that "our facility placed a 20 cm central venous catheter on a patient (b)(6) 2023.While passing the wire, the patient jerked, and the wire bent.While sliding the wire out, the atraumatic tip frayed and broke off leaving a piece of the wire partially in the vein, but also within the soft tissues.The patient was taken to surgery to have it removed".No patient harm or injury.The patient status is reported as "stable".

• Brand Name: PI CVC KIT: 3L 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18394339
• MDR Text Key: 331332682
• Report Number: 9680794-2023-01021
• Device Sequence Number: 1
• Product Code: FOZ
• 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: Consumer,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/30/2023

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 Catalogue Number: ASK-45703-PNHS1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/30/2023
• Initial Date FDA Received: 12/26/2023
• Supplement Dates Manufacturer Received: 01/17/2024
• Supplement Dates FDA Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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