MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAP

Catalog Number	CDC-45703-P1A
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reports the needle bends after insertion into the patient "with little force/torque and only while in soft issue" and when the needle has been retracted out of the patient "any attempt to correct the needle structure results in snapping at the base near the syringe port hub".There was no patient harm, "only prolonged procedural time and multiple procedural attempts".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Customer reports the needle bends after insertion into the patient "with little force/torque and only while in soft issue" and when the needle has been retracted out of the patient "any attempt to correct the needle structure results in snapping at the base near the syringe port hub".There was no patient harm, "only prolonged procedural time and multiple procedural attempts".
Additional Manufacturer Narrative
(b)(4).The customer provided seven images and a video for analysis showing damage to the introducer needle.The customer provided images/video do not show the damage to the 20ga needle (n-04018-001a) from the catheter-over-needle assembly; therefore, no conclusions can be made from the photos/video about the damage to the 20ga needle.The customer also returned one opened cvc kit, including one catheter-over-needle assembly, for analysis.The needle was returned with the catheter from the assembly advanced off of the needle cannula.No definite signs of use were observed.Visual analysis of the 20ga needle cannula revealed that it contained a slight bend adjacent to the hub.Microscopic examination confirmed the bend.No obvious defects or anomalies were observed on the catheter.It was noted that the introducer needle was broken.The bend in the needle cannula measured 2mm from the luer hub.The outer diameter of the needle cannula measured 0.0355" which is within the specification limits of 0.0355" - 0.0360" per the cannula graphic.The inner diameter of the needle cannula measured 0.0230" which is within the specification limits of 0.0230" - 0.0245" per the cannula graphic.This indicates that the wall thickness of the needle met required dimensional specifications.The needle was functionally tested per the instructions for use (ifu) provided with this kit which instru cts the user, "insert introducer needle or catheter/needle with attached syringe or arrow raulerson syringe (where provided) into vein and aspirate." the needle was connected with the returned ars and was able to draw and aspirate water as intended.Manufacturing was consulted as a part of this complaint, and they stated that the manufacturing process of the needle with the hub involves no movement that would bend the needle.Additionally, the process is 100% inspected to detect damage to the cannula.They proposed that the damage appears consistent with an undue force applied on the needle either during handling of the needle during the shipping/transport process or by the user.Therefore, at this time, based on the available information, it cannot be confirmed when the damage occurred.A device history record review was performed, and no relevant findings were identified to suggest a manufacturing related issue.The customer report of a bent needle was confirmed through investigation of the returned sample.The returned 20ga needle contained a slight bend adjacent to the hub.Dimensional analysis of the needle revealed the cannula met wall thickness dimensional requirements and a device history record review for this batch did not reveal any relevant findings to suggest a manufacturing related issue.The manufacturing facility was consulted and they stated that the needles are 100% inspected to detect damage of the cannula, and that the bend observed is consistent with damage resulting from either device handling and/or shipping/storage of the product.Based on these circumstances, the potential root cause cannot be determined at this time as it cannot be confirmed when the damage occurred.Teleflex will continue to monitor and trend on reports of this nature.

• Brand Name: ARROW MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM
• Common Device Name: 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: 17625479
• Report Number: 9680794-2023-00603
• Device Sequence Number: 6202049
• Product Code: FOZ
• UDI-Device Identifier: 10801902117189
• UDI-Public: 10801902117189
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: CDC-45703-P1A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2023
• Supplement Date Received by Manufacturer: 12/06/2023
• Initial Report FDA Received Date: 08/25/2023
• Supplement Report FDA Received Date: 12/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown