MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PARACENTESIS KIT; KIT SURGICAL INSTRUMENT DISPOS

Catalog Number AK-00376

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 09/30/2021

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

Customer reports tubing with roller clamp leaks.Leaking comes right at the edge of the connect to the catheter.There is a vibration and whistling noise coming from the tubing.No report of patient harm.

Event Description

Customer reports tubing with roller clamp leaks.Leaking comes right at the edge of the connect to the catheter.There is a vibration and whistling noise coming from the tubing.No report of patient harm.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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.Corrected data: section h.6.-medical device problem code corrected to 1354.

• Brand Name: ARROW PARACENTESIS KIT
• Type of Device: KIT SURGICAL INSTRUMENT DISPOS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• 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: 12715190
• MDR Text Key: 280899745
• Report Number: 9680794-2021-00585
• Device Sequence Number: 1
• Product Code: KDD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K874063
• 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: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: AK-00376
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/30/2021
• 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: COOK YUEH CATHETER; COOK YUEH CATHETER