MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MULTILUMEN/PSI KIT 9 FR X 11.5 CM; CATHETER,INTRAVASCULAR,THERAP

Model Number IPN036272

Device Problems Leak/Splash (1354); Improper Flow or Infusion (2954)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/11/2023

Event Type  malfunction  

Event Description

It was reported when trying to pull back, there was no blood return in both white and brown lumens.Before starting high concentration pressors in white lumen the nurse noticed no blood return, but no issues with flushing the line.The nurse was told it was okay to run pressors in the white lumen.The brown lumen had single strength pressors running when switching over to high concentrated pressors.When pulling back brown lumen, the nurse noticed air in tubing with no blood return, the 10cc plunger would fill up with air along with pressor medication.The cvc had been inserted in the right jugular for one day and the issue was identified upon arrival from or.No patient harm was reported.The brown lumen was marked as "do not use", but the introducer was kept in place and white lumen used.The central line was removed nine days later.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).The customer returned one catheter for analysis.Signs of use in the form of biomaterial were observed.Visual analysis of the catheter did not reveal any obvious defects or anomalies.The outer diameter of the distal extension line measured 4.793mm which is within the specification limits of 4.70mm - 4.80mm per the distal extension line product drawing.The inner diameter of the distal extension line measured 2.9718mm, which is within the specification limits of 2.90mm - 3.00mm per the distal extension line product drawing.The outer diameter of the proximal extension line measured 2.924mm which is within the specification limits of 2.90mm - 3.00mm per the distal extension line product drawing.The inner diameter of the distal extension line measured 2.1336mm, which is within the specification limits of 2.11mm - 2.21mm per the distal extension line product drawing.The valve and psi device were leak tested according to three different parameters per amrq-000037 rev10: 1.) low pressure leak resistance test (amrq-000037 section 6.1.2): this states, "using a test pressure of 38-42kpa (5.51-6.09psi), there shall be no leakage past the hemostasis valve " the psi catheter was attached to the lab leak tester.With the distal end of the sheath occluded, the sheath was pressurized to 42kpa for 30 seconds.No leaking was observed.2.) liquid leakage - hemostasis valve with catheter inserted: the parameters from the low-pressure leak resistance test were repeated with a lab inventory catheter inserted into the sheath.The sheath was pressurized with to 21kpa for 30 seconds and no leaks were observed from the hemostasis valve.3.) high pressure leak resistance test (amrq-000037 section 6.1.3): this states, "when tested in accordance with iso 11070:, annex d, using a test pressure of 300-320 kpa (43.5 - 46.4 psi) there shall be no leakage sufficient to form a falling drop." with both the distal end of the sheath and the hemostasis valve occluded, the device was pressurized to 300kpa for 30seconds.No leaks were detected from any portion of the psi, which indicates that the assembly is intact.A manual tug test confirmed that the extension lines were secure within their respective luer hubs.A device history record review was performed, and no relevant findings were identified.The ifu as part of this complaint instructs the user, "do not secure, staple and/or suture directly to outside diameter of device body or extension lines to reduce risk of cutting or damaging the device or impeding device flow.Secure only at indicated stabilization locations." the customer report of an extension line leak could not be confirmed through investigation of the returned sample.The catheter passed all relevant dimensional and functional requirements including leak testing performed per iso 11070.A device history record review revealed no relevant findings.Based on the customer report and the sample received, no problem was found.Teleflex will continue to monitor and trend on reports of this nature.

Event Description

It was reported when trying to pull back, there was no blood return in both white and brown lumens.Before starting high concentration pressors in white lumen the nurse noticed no blood return, but no issues with flushing the line.The nurse was told it was okay to run pressors in the white lumen.The brown lumen had single strength pressors running when switching over to high concentrated pressors.When pulling back brown lumen, the nurse noticed air in tubing with no blood return, the 10cc plunger would fill up with air along with pressor medication.The cvc had been inserted in the right jugular for one day and the issue was identified upon arrival from or.No patient harm was reported.The brown lumen was marked as "do not use", but the introducer was kept in place and white lumen used.The central line was removed nine days later.The patient's condition is reported as fine.

• Brand Name: ARROW MULTILUMEN/PSI KIT 9 FR X 11.5 CM
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• 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: 17273595
• MDR Text Key: 318602077
• Report Number: 9680794-2023-00488
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011761
• 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: 06/12/2023

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 Expiration Date: 05/31/2024
• Device Model Number: IPN036272
• Device Catalogue Number: ASK-21242-MMC1
• Device Lot Number: 33F23B0671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/12/2023
• Initial Date FDA Received: 07/06/2023
• Supplement Dates Manufacturer Received: 07/31/2023
• Supplement Dates FDA Received: 08/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2023
• 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: NOT REPORTED.; NOT REPORTED.