MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC HEMODIALYSIS SET: 2-LUMEN 14 FR X 20 CM; CATHETER HEMODIALYTSIS NON IMP

Catalog Number CS-25142-F

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/30/2023

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(6).N/a.Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that "a confused patient managed to pull his arrowgard 20cm dual lumen hemodialysis catheter (product code cs-25142-f) through the suture plate.This stopped hemodialysis treatment and involved some blood loss although the patient's clinical condition did not change dramatically".Additional information received states that "there was no obvious change in [hemoglobin] and no blood transfusion required.No specific medical or surgical intervention was required, and there was no obvious harm, or obvious sign of the patient being more unwell than he was already, although how he felt would have been difficult to determine given his pre-existing confusion.A new line was placed in the same right femoral area the following day".The patient status is reported as "fine".

Event Description

It was reported that "a confused patient managed to pull his arrowgard 20cm dual lumen hemodialysis catheter (product code cs-25142-f) through the suture plate.This stopped hemodialysis treatment and involved some blood loss although the patient's clinical condition did not change dramatically".Additional information received states that "there was no obvious change in [hemoglobin] and no blood transfusion required.No specific medical or surgical intervention was required, and there was no obvious harm, or obvious sign of the patient being more unwell than he was already, although how he felt would have been difficult to determine given his pre-existing confusion.A new line was placed in the same right femoral area the following day".The patient status is reported as "fine".

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed based on a potential lot from sales history, and 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.Other remarks: n/a.Corrected data: n/a.

• Brand Name: HEMODIALYSIS SET: 2-LUMEN 14 FR X 20 CM
• Type of Device: CATHETER HEMODIALYTSIS NON IMP
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18196299
• MDR Text Key: 328982034
• Report Number: 3006425876-2023-01138
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 00801902100221
• UDI-Public: 00801902100221
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K993933
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/30/2023

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 Operator: Health Professional
• Device Catalogue Number: CS-25142-F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/30/2023
• Initial Date FDA Received: 11/22/2023
• Supplement Dates Manufacturer Received: 12/15/2023
• Supplement Dates FDA Received: 12/18/2023
• 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: N/A.; N/A.
• Patient Sex: Male