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

Catalog Number CDC-45703-XPB1A

Device Problem Stretched (1601)

Patient Problem Insufficient Information (4580)

Event Date 09/12/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer reported that the white port lumen of the triple lumen catheter expanded beyond a normal size inside a patient and had to be removed.Patient received ct contrast from a power injector prior to the ballooning of the lumen.Before going to ct scan, all lumens were checked for patency and blood return (which all ports had without issue).

Event Description

Customer reported that the white port lumen of the triple lumen catheter expanded beyond a normal size inside a patient and had to be removed.Patient received ct contrast from a power injector prior to the ballooning of the lumen.Before going to ct scan, all lumens were checked for patency and blood return (which all ports had without issue).

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

• Brand Name: ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• 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: 15545321
• MDR Text Key: 306687971
• Report Number: 9680794-2022-00622
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: CDC-45703-XPB1A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/01/2022
• 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
• Treatment: CT WITH CONTRAST; CT WITH CONTRAST