MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER PERCUTANEOUS

Catalog Number	CS-15703
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: in view of a transfer to a different hospital department in the next few days, the number of lines had to be reduced, so one of the lines had to be clamped and heparinized.At the time of treatment, the nurse wanted to remove the infusion line to close the line.When she tried to unscrew the line from the extension with tap, the junction broke.Consequences confirmed: line was impossible to use.Line was clamped.The patient was reported as fine, there was no reproted patient harm or consequence.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4), the report of a separated extension line/luer hub cannot be confirmed through analysis of the customer supplied photo.The customer provided one image showing a connector tubing and a stopcock.Visual analysis could not confirm the complaint as there was no clear visual evidence of a separation.Additionally, further analysis of the bill of materials revealed that neither a stopcock nor connector tubing are included within this finished kit.Therefore, it can be concluded that the pictured component is likely not an arrow device packaged within the reported finished kit.A device history record review was performed based on sales history, and no relevant findings were identified.Based on the customer report and the analysis of the customer photo, the root cause cannot be determined at this time.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: in view of a transfer to a different hospital department in the next few days, the number of lines had to be reduced, so one of the lines had to be clamped and heparinized.At the time of treatment, the nurse wanted to remove the infusion line to close the line.When she tried to unscrew the line from the extension with tap, the junction broke.Consequences confirmed: line was impossible to use.Line was clamped.The patient was reported as fine, there was no reported patient harm or consequence.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18865960
• Report Number: 3006425876-2024-00216
• Device Sequence Number: 18202676
• Product Code: DQY
• UDI-Device Identifier: 30801902125959
• UDI-Public: 30801902125959
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 02/13/2024

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-15703
• Device Lot Number: UNKNOWN
• 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: 02/13/2024
• Supplement Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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