MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS KIT: 2-L 15 FR X 23 CM; CATHETER, HEMODIALYSIS, IMPLA

Model Number IPN920517

Device Problems Leak/Splash (1354); Fitting Problem (2183)

Patient Problem Insufficient Information (4580)

Event Date 05/24/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer reported prior issue of "green seal is too large.When the hub is tightened, the seal is pushed over the thread and leads to leakage (air is drawn during aspiration)." no patient information was available.It was reported in each case the issue could be solved by using a replacement hub.It was unknown how many times the issue occurred.

Event Description

Customer reported prior issue of "green seal is too large.When the hub is tightened, the seal is pushed over the thread and leads to leakage (air is drawn during aspiration)." no patient information was available.It was reported in each case the issue could be solved by using a replacement hub.It was unknown how many times the issue occurred.

Manufacturer Narrative

Qn#(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.

• Brand Name: ARROW HEMODIALYSIS KIT: 2-L 15 FR X 23 CM
• Type of Device: CATHETER, HEMODIALYSIS, IMPLA
• 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: 14701673
• MDR Text Key: 295493638
• Report Number: 9680794-2022-00382
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 30801902195556
• UDI-Public: 30801902195556
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K111117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN920517
• Device Catalogue Number: CS-15232-X
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2022
• 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