MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI CVC KIT: 4-L 8.5 FR X 20 CM AGB+; CATHETER,INTRAVASCULAR,THERAPE

Model Number IPN922683

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 04/20/2022

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).The mdr report key/report number is 14309035.The mdr text key is 290957739.

Event Description

Complaint found in maude database reports: "gray port snapped off from lumen.".

Event Description

Complaint found in maude database reports: "gray port snapped off from lumen.".

Manufacturer Narrative

Qn# (b)(4).The mdr report key/report number is 14309035.The mdr text key is 290957739.Complaint verification testing could not be performed as it was reported that the sample is not available for return.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: 4-L 8.5 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: 14979074
• MDR Text Key: 304596024
• Report Number: 9680794-2022-00413
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10801902202557
• UDI-Public: 10801902202557
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: IPN922683
• Device Catalogue Number: ASK-45854-BJC1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/09/2022
• 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: NOT REPORTED; NOT REPORTED