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
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bends after insertion into the patient "with little force/torque and only while in soft issue" and when the needle has been retracted out of the patient "any attempt to correct the needle structure results in snapping at the base near the syringe port hub".There was no patient harm, "only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".
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bends after insertion into the patient "with little force/torque and only while in soft issue" and when the needle has been retracted out of the patient "any attempt to correct the needle structure results in snapping at the base near the syringe port hub".There was no patient harm, "only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 actual device was not returned; however, the customer provided seven photos and one video for analysis.The images show the several needles with broken cannulas adjacent to the hub and a label with a potential lot# listed (13f23a0450).The video shows the customer replicating the damage observed by intentionally bending and breaking an introducer needle cannula.A complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed based on the potential lot number provided by the customer, and no relevant findings were identified.The customer report of needle cannula broke was confirmed by visual inspection of the customer supplied photos and video.The photos and video show introducer needles with broken cannulas adjacent to the hub , however, full complaint verification testing and root cause analysis could not be performed without the sample returned for analysis.A device history record review was performed based on the potential lot provided by the customer, and no relevant findings were identified to suggest a manufacturing related issue.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for 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: 17643700
• Report Number: 9680794-2023-00623
• Device Sequence Number: 5680278
• 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): 08/05/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2023
• Supplement Date Received by Manufacturer: 09/22/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 09/28/2023
• 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