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

Catalog Number	CS-25802-E
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the ars was found damaged during used on the patient".No report of patient harm or injury.The patient status is reported as "fine".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.
Additional Manufacturer Narrative
Qn# (b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Additional Manufacturer Narrative
Qn#(b)(4) bd changed from ars leak to needle hub crack by engineers after visual analysis of the customer supplied video.Remains reportable.Codes added.The customer report of a cracked needle hub was confirmed through visual inspection of the customer supplied video.The returned video shows leaking from a crack on the needle hub.A device history record review was performed with no findings relevant to this investigation.Based on these circumstances and the comments from r & d, the root cause of this complaint is design related.Teleflex has identified that this needle hub material is susceptible to cracking when placed under stress (i.E.Pressed onto a tapered luer fitting, sideloaded as the clinician attempts to locate a vessel, etc.) in the presence of liquid alcohol-based disinfectants.An investigation was implemented (b)(6)2023 using a new alcohol-resistant material to manufacture the needle hub.The manufacturing date for the needle hub involved with this complaint occurred prior to the investigation's implementation date.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a corrected data: n/a.
Event or Problem Description
It was reported that "the ars was found damaged during used on the patient".No report of patient harm or injury.The patient status is reported as "fine".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.
Event or Problem Description
It was reported that "the ars was found damaged during used on the patient".No report of patient harm or injury.The patient status is reported as "fine".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.
Additional Manufacturer Narrative
Qn# (b)(4).Udi related data quality updates only.Section d.4.-unique identifier (udi)# corrected to (b)(4).

• Brand Name: ARROW CVC SET: 2-LUMEN 8 FR X 20 CM
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18401333
• Report Number: 3006425876-2023-01282
• Device Sequence Number: 3968035
• Product Code: FOZ
• UDI-Device Identifier: 00801902102331
• UDI-Public: (01)00801902102331(11)220915(17)240831(10)71F22J0589(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K900263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/04/2023

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 Expiration Date: 08/31/2024
• Device Catalogue Number: CS-25802-E
• Device Lot Number: 71F22J0589
• 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: 12/04/2023
• Supplement Date Received by Manufacturer: 01/18/2024; Not provided
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 01/19/2024; 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2022
• 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: N/A.; N/A.; N/A.
• Patient Sex: Unknown