MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MULTILUMEN CVC KIT: 3L 7 FR X 30 CM; CATHETER, PERCUTANEOUS

Catalog Number SA-14703-J

Device Problem Material Twisted/Bent (2981)

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

Event Date 01/24/2024

Event Type  malfunction  

Event Description

It was reported "when the user advanced the swg from the advancer before use, it was found kinked.Therefore, another swg from another kit was used instead".No patient involvement.Therefore no patient harm or injury.

Manufacturer Narrative

(b)(4).

Event Description

It was reported "when the user advanced the swg from the advancer before use, it was found kinked.Therefore, another swg from another kit was used instead".No patient involvement.Therefore no patient harm or injury.

Manufacturer Narrative

Qn# (b)(4).The report of a kinked spring wire guide was confirmed through examination of the returned sample.The customer provided one image s howing a guide wire and returned one guide wire with tubing for analysis.The straightener tub and the cap were not returned with the sample.Signs-of-use in the form of biological material were observed on the sample, which does not match the customer report of " prior to use".The customer was also contacted regarding the signs-of-use.They confirmed that any biological material was likely introduced due to handling in the clinical setting.Visual analysis revealed that the guide wire contained one major kink.Microscopic examination confirmed the damage.Both welds were observed to be full and spherical.No other defects or anomalies were observed with the guide wire nor the returned tray.Visual analysis could not be performed on the guide wire straightener or cap as they were not returned for analysis.The kink on the guide wire measured 640mm via calibrated ruler from the proximal weld.The guide wire length measured 685mm via calibrated ruler, which was within the specification limits of 679mm-687mm per the guide wire product drawing.The guide wire outer diameter measured 0.079mm via calibrated caliper, which was within the specification limits of 0.788mm-0.826mm per the guide wire product drawing.Functional inspection was performed per ifu statement, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle".The guide wire was inserted through a lab inventory ars/introducer needle subassembly.Resistance was encountered at the kinking; however, the guide wire passed with little to difficulty.A manual tug test confirmed that the distal and proximal welds were secure and intact.The ifu provided with the kit informs the user, "do not use if package is damaged".A device history record review was performed, and no relevant findings were identified.During normal assembly within lab inventory tubing, the kink on the guide wire would have been protected within the straightener during packaging, shipping, and storage.However, as the complete tubing assembly was not returned, it could not be verified if any damages contributed to the kinking on the guide wire.Therefore, it is unknown if the guide wire became kinked before or after the customer handled.Based on the customer report and sample received, the potential root cannot be determined at this time.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW MULTILUMEN CVC KIT: 3L 7 FR X 30 CM
• Type of Device: CATHETER, PERCUTANEOUS
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18707421
• MDR Text Key: 335387313
• Report Number: 3006425876-2024-00117
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/24/2024

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: SA-14703-J
• Device Lot Number: 71F23C0135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 02/14/2024
• Supplement Dates Manufacturer Received: 03/13/2024
• Supplement Dates FDA Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2023
• 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