MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 8 FR X 20 CM; CATHETER PERCUTANEOUS

Catalog Number	CS-15802-E
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported "introducer needle bent".There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned one catheter over needle component.No obvious signs of use were observed.Visual analysis revealed that the needle hub was not flush with the hub of the catheter.The needle was removed , and a bend was located on the cannula directly adjacent to the needle hub.The location of this bend is located inside the hub of the catheter.Once removed, the catheter body did not show abnormalities or bending; however, microscopic examination revealed scratch marks on the inside of the needle guard.These scratch marks were located adjacent to the needle tip and also traveled along the length of the guard.The bend measured 2mm from the hub.The cannula outer diameter measured 0.0355", which is within the specification limits of 0.0355"-0.0360" per the cannula product drawing.The cannula inner diameter at the distal and proximal ends measured 0.023", which is within the specification limits of 0.023"-0.0245" per the cannula product drawing.The manufacturing facility was contacted as part of this complaint investigation.They indicated that needles of this type are 100% inspected for such damage.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 report of a bent needle was confirmed through complaint investigation of the returned sample.Visual analysis revealed a slight bend adjacent to the needle hub from the catheter over needle subassembly.Despite the damage, the sample met all relevant dimensional and functional requirements, and a device history record review did not reveal any relevant findings.Based on the customer report that the bending was detected "during use" and the comments from manufacturing, the root cause cannot be determined as is unknown if the failure occurred before or after the customer handled.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "introducer needle bent".There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW CVC SET: 2-LUMEN 8 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: 20098740
• Report Number: 3006425876-2024-00859
• Device Sequence Number: 7747716
• Product Code: DQY
• UDI-Device Identifier: 40801902127745
• UDI-Public: (01)40801902127745(11)230207(17)280131(10)71F23B0216(21)
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 08/08/2024

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 Catalogue Number: CS-15802-E
• Device Lot Number: 71F23B0216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 08/29/2024
• Supplement Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2023
• 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