MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 30 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CS-24703-E
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the white luer-hub was broken when it was unscrewed.The catheter remained in place for a total of 4 days before the breakage occurred.The leur hub was cracked.There was no reported patient harm or consequence.".
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that "the white luer-hub was broken when it was unscrewed.The catheter remained in place for a total of 4 days before the breakage occurred.The leur hub was cracked.There was no reported patient harm or consequence.".
Additional Manufacturer Narrative
(b)(4).The customer provided one photo for analysis.The photo shows a separated proximal extension line.The customer also returned one, 3-lumen catheter for analysis.Signs of use were observed.The catheter body appeared intentionally severed towards the juncture hub.Visual and microscopic analysis confirmed the separation point on the proximal extension line was rough and jagged.A portion of the extension line was still molded within the separated luer hub.This damage is consistent with a manufacturing molding defect.The outer diameter of the extension line measured 2.13 mm, which is within the specification limits of 2.13-2.21 mm per proximal extension line extrusion product drawing.The inner diameter of the proximal extension line measured 1.47 mm, which is within the specification limits of 1.42-1.50 mm per proximal extension line extrusion product drawing.A manual tug test confirmed the other extension lines were secure within their respective luer hubs.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested.Do not secure, staple and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations." the report of extension line/luer hub separation was confirmed through complaint investigation of the returned sample.Visual and microscopic analysis revealed the proximal extension line was separated from the luer hub.A portion of the extension line was still molded within the separated luer hub, which is consistent with past manufacturing molding complaints.Based on the appearance of the damage, manufacturing caused or contributed to this event.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend complaints of this nature.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 30 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: 20320700
• Report Number: 3006425876-2024-00922
• Device Sequence Number: 8183613
• Product Code: FOZ
• UDI-Device Identifier: 00801902102287
• UDI-Public: (01)00801902102287(11)231030(17)250919(10)71F23K1103(21)
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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
• Report Date (Section B): 09/04/2024

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 Expiration Date: 09/19/2025
• Device Catalogue Number: CS-24703-E
• Device Lot Number: 71F23K1103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Supplement Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2023
• 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