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

Catalog Number CDC-42703-XP1A

Device Problem Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Date 01/23/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported "the introducer needle slides off the syringe if gel or blood gets on it.The introducer needle does not stay stationary when place on the syringe".Additional information was requested from the customer, no additional information available at this time.

Manufacturer Narrative

(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.An engineering change order was created to add an 'ars supply shortage' label to these kits.A substitute 5ml syringe has been added to replace the ars.Without the sample returned, it cannot be confirmed if this substitute syringe caused or contributed to the reported defect.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

It was reported "the introducer needle slides off the syringe if gel or blood gets on it.The introducer needle does not stay stationary when place on the syringe".Additional information was requested from the customer, no additional information available at this time.

• Brand Name: ARROW PI CVC KIT: 3L 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: 19172911
• MDR Text Key: 341475741
• Report Number: 9680794-2024-00368
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10801902117080
• UDI-Public: 10801902117080
• 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: 03/29/2024

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-42703-XP1A
• Device Lot Number: 33F23G0150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/29/2024
• Initial Date FDA Received: 04/24/2024
• Supplement Dates Manufacturer Received: 05/16/2024
• Supplement Dates FDA Received: 05/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2023
• 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.