MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM; CATHETER PERCUTANEOUS

Model Number	IPN919728
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "the introducer needle has bent during puncture which could create deviation and is not safe." the device was removed and replaced.There was no delay to therapy and no patietn harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).The actual device was not returned; however, the customer provided one photo for analysis.The complaint of bent needle was able to be confirmed by the photo.The bend was located towards the needle hub.Signs of use were also observed inside the needle hub, which confirms the customer report of 'during use'; however, a complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not alter the catheter, guidewire or any other kit/set component during insertion, use or removal".The ifu also states, "do not use if package is damaged".The customer report of a bent needle was confirmed by visual inspection of the customer supplied photo.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.Corrected data: unique identifier (udi)# corrected from (b)(4).
Event or Problem Description
It was reported "the introducer needle has bent during puncture which could create deviation and is not safe." the device was removed and replaced.There was no delay to therapy and no patietn harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
• Common Device Name: 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19476454
• Report Number: 3006425876-2024-00566
• Device Sequence Number: 19828919
• Product Code: DQY
• UDI-Device Identifier: 10801902100280
• UDI-Public: 10801902100280
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2024

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
• Operator of Device: Health Professional
• Device Model Number: IPN919728
• Device Catalogue Number: CV-15122-F
• Device Lot Number: 71F23D0768
• 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: Not provided
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2023
• 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: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown