MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 12 FR X 16 CM; CATHETER PERCUTANEOUS

Catalog Number	CS-12123-F
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that"on (b)(6) , the emergency (b)(6) hospital notified the dealer of the (b)(6) hemodialysis catheter used by the hospital.The patient underwent puncture of the catheter for dialysis at the hospital, and then left the hospital to go home.During their stay at home, the catheter fell off and was immediately sent to the hospital for rescue.The doctor reported tearing of the sutured wing and suspected quality issues with the product.Therefore, an adverse event was reported to the medical department.At present, there is no further notice from the hospital or clinical department." awaiting additional information as the model number provided is a 3 lumen cvc but the event description reported a hemodialysis catheter.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer report of a torn suture wing was confirmed by visual inspection of the customer supplied photo.The torn suture wing edges were jagged, indicating likely undue force being applied on the catheter.The instructions for use (ifu) provided with this kit warns the user, "secure catheter clamp and fastener as a unit to patient by using either catheter stabilization device, stapling or suturing.Both catheter clamp and fastener need to be secured to reduce risk of catheter migration." a device history record review was performed, and no relevant findings were identified.Based on these circumstances, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that"on january 15th, the emergency general hospital notified the dealer of the cs-12123-f hemodialysis catheter used by the hospital.The patient underwent puncture of the catheter for dialysis at the hospital, and then left the hospital to go home.During their stay at home, the catheter fell off and was immediately sent to the hospital for rescue.The doctor reported tearing of the sutured wing and suspected quality issues with the product.Therefore, an adverse event was reported to the medical department.At present, there is no further notice from the hospital or clinical department." awaiting additional information as the model number provided is a 3 lumen cvc but the event description reported a hemodialysis catheter.

• Brand Name: ARROW CVC SET: 3-LUMEN 12 FR X 16 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18693499
• Report Number: 3006425876-2024-00203
• Device Sequence Number: 12851408
• Product Code: DQY
• UDI-Device Identifier: 00801902102119
• UDI-Public: 00801902102119
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: CS-12123-F
• Device Lot Number: 71F22J3276
• 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: 01/18/2024
• Supplement Date Received by Manufacturer: 03/06/2024
• Initial Report FDA Received Date: 02/13/2024
• Supplement Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2022
• 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