MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 12 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CS-15123-F
Medical Device Problem Codes	Crack (1135); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported "during the procedure when the doctor attempted to aspirate it was noticed that there was only air coming through.Upon investigation of the needle by the doctor it was noticed that there was a crack on the hub.Another complete set was opened and the procedure completed successfully." 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 actual device is not available for return; however, the customer provided one photo for analysis.The complaint of a cracked needle hub was not able to be confirmed through analysis of the photo.No obvious cracking is visible; 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 instructions-for-use (ifu) provided with this kit warns the user, "some disinfectants used at catheter insertion site contain solvents which can weaken the catheter material.Alcohol, acetone , and polyethylene glycol can weaken the structure of polyurethane materials." it also states "do not use polyethylene glycol containing ointments at insertion site." the customer report of a cracked needle hub could not confirmed by visual inspection of the customer supplied photo.The image shows an introducer needle, however, no cracks can be seen in the hub based on the photo quality.A full complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.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.
Event or Problem Description
It was reported "during the procedure when the doctor attempted to aspirate it was noticed that there was only air coming through.Upon investigation of the needle by the doctor it was noticed that there was a crack on the hub.Another complete set was opened and the procedure completed successfully." 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: 3-LUMEN 12 FR X 20 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• 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: 20459637
• Report Number: 3006425876-2024-00997
• Device Sequence Number: 20782065
• Product Code: FOZ
• UDI-Device Identifier: 00801902102164
• UDI-Public: (01)00801902102164(11)240425(17)290228(10)71F24B1395(21)
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K970864
• 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): 09/20/2024

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-15123-F
• Device Lot Number: 71F24B1395
• 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: 09/20/2024
• Supplement Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2024
• 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