MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2L 5 FR X 13 CM; CATHETER PERCUTANEOUS

Catalog Number	CS-14502
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that: the adapter was detached from the distal lumen of the extension.Additional information has been requested from the account.
Additional Manufacturer Narrative
(b)(4).The actual sample was not returned; however, the customer provided one photo for analysis.The complaint of an extension line/luer hub separation was able to be confirmed from the photo; however, a complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed.A non-conformance was initiated for batch 13c20h0549 in regards to reworking of catheters.Further analysis of this non-conformance revealed that the rework has no impact on the physical device.The ifu provided with the kit informs the user, "do not apply excessive force in removing guide wire or catheters.If withdrawal cannot be easily accomplished, a chest x-ray should be obtained and further consultation requested".The ifu also states, "to minimize the risk of damage to extension lines from excessive pressure, each clamp must be opened prior to infusing through that lumen".The customer report of an extension line/luer hub separation was confirmed by visual inspection of the customer supplied photo.The image shows a catheter with the distal luer hub separated from the extension line, however, full complaint verification testing to evaluate the nature of the break could not be performed as no sample was returned for analysis.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 that: the adapter was detached from the distal lumen of the extension.Additional information received 19-jan-2024 indicates there was no patient injury/harm.It was also reported that "the catheter was changed at a different insertion site".
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that: the adapter was detached from the distal lumen of the extension.Additional information received 19-jan-2024 indicates there was no patient injury/harm.It was also reported that "the catheter was changed at a different insertion site".

• Brand Name: ARROW CVC SET: 2L 5 FR X 13 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: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18159832
• Report Number: 3006425876-2023-01174
• Device Sequence Number: 6420719
• Product Code: DQY
• UDI-Device Identifier: 30801921122939
• UDI-Public: (01)30801921122939(11)201026(17)250228(10)71F20K1601(21)
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/24/2023

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
• Device Expiration Date: 02/28/2025
• Device Catalogue Number: CS-14502
• Device Lot Number: 71F20K1601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2023
• Supplement Date Received by Manufacturer: 05/03/2024; Not provided
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 05/03/2024; 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2020
• 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; NOT REPORTED
• Patient Sex: Unknown