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bends after insertion into the patient "with little force/torque and only while in soft issue" and when the needle has been retracted out of the patient "any attempt to correct the needle structure results in snapping at the base near the syringe port hub".There was no patient harm, "only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).
Additional Manufacturer Narrative
(b)(4).The customer provided six images and a video for analysis showing a defective needle.The kit lidstock was also pictured.The pictures showed that the needle cannula was separated towards the needle hub.Analysis of the video shows the customer intentionally bending the needle cannula, which resulted in the separation to occur.The customer returned one, opened cvc kit for analysis.No obvious signs of use were observed.Visual analysis revealed that the cannula on the returned introducer needle was separated towards the needle hub.A slight bend was also observed around the middle of the cannula.Microscopic examination confirmed the separation and revealed that the cannula was slightly bent and oval at both ends of the separation.It cannot be determined if this location of the cannula was defective prior to the customer bending (per customer supplied video).It was also noted that the needle from the catheter over needle was bent.The point of separation on the needle cannula measured 4mm from the needle hub.The cannula outer diameter (in an area not affected by the damage) measured 0.0500", which is within the specification limits of 0.0495"-0.0505" per the cannula product drawing.The cannula inner diameter measured at the proximal end distal ends measured 0.041", which is within the specifica tion limits of 0.041"-0.043" per the cannula product drawing.The returned guide wire was inserted through the defective cannula.The guide wire met slight resistance at both point of separation; however, the guide wire was still able to pass completely through the cannula.Performed per ifu statement, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle".The sample was sent for additional analysis.It was confirmed that the needle cannula passed the iso test criteria for flexing for the gauge size and wall thickness.There is no indicator that the needle has any type of manufacturing defect.A device history record review was performed based on the lot# returned, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not use if package is damaged".The report of a separated needle cannula was confirmed through complaint investigation.Visual examination revealed that the cannula was separated 4mm from the needle hub.The cannula appeared bent and oval at both ends of the separation which is consistent with a bend resulting in a break.Undamaged portions of the needle cannula met all relevant dimensional requirements, and a device history record review did not reveal any relevant findings to suggest a manufacturing related issue.Testing of the returned cannula performed by r & d confirmed that the needle cannula passed the iso test criteria for flexing for the gauge size and wall thickness.There is no indicator that the needle has any type of manufacturing defect.Based on the customer report, the sample received, analysis of the customer supplied video, and the analysis performed by r & d, the root cause cannot be determined as it is unknown of the needle cannula was damaged prior to the customer bending (per supplied video).Teleflex will continue to monitor and trend for reports of this nature.
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".

• 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: 17625342
• Report Number: 9680794-2023-00602
• Device Sequence Number: 7386380
• 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: 11/30/2023
• Initial Report FDA Received Date: 08/25/2023
• Supplement Report FDA Received Date: 12/01/2023
• 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