MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 4-LUMEN 8.5 FR X 20 CM; CATHETER PERCUTANEOUS

Catalog Number	CS-15854-E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "when the user attempted to flush the catheter after placement, leak was confirmed near the junction hub.Therefore, the catheter was removed and replaced with a new kit (lot#: unknown).No injury to the patient occurred".The patient status is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4) the report of a leaking catheter body was confirmed through complaint investigation of the returned sample.The customer returned one, 4-lumen cvc for analysis.Signs-of-use in the form of biological material were observed inside the extension lines.After failing functional testing, a leak was observed on the catheter body.Microscopic examination confirmed that the edges of the hole were straight and uniform which is indicative of contact with sharps.The hole on the catheter body measured 86mm via calibrated ruler from the juncture hub.The catheter body total length measured 221mm via calibrated ruler, which was within the specification limits of 207mm-227mm per the catheter product drawing.The catheter body outer diameter measured 2.90mm via calibrated caliper, which was within the specification limits of 2.87mm-2.97mm per the catheter body extrusion product drawing.Functional inspection was performed per ifu statement, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)".The catheter body was occluded at the distal end and all four extension lines were flushed with a lab inventory syringe.When flushing the medi a1 lumen (gray hub), water was observed leaking from a hole on the catheter body.No leaks were noted when flushing any of the other three extension lines.The ifu provided with the kit informs the user, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)".The ifu also states, "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".A device history record review was performed, and no relevant findings were identified.Microscopic examination confirmed that the edges of the hole were straight and uniform which was indicative of contact with sharps.Therefore, based on the customer report and the sample received, unintentional user error likely caused or contributed to this event.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 "when the user attempted to flush the catheter after placement, leak was confirmed near the junction hub.Therefore, the catheter was removed and replaced with a new kit (lot#: unknown).No injury to the patient occurred".The patient status is reported as "fine".
Event or Problem Description
It was reported that "when the user attempted to flush the catheter after placement, leak was confirmed near the junction hub.Therefore, the catheter was removed and replaced with a new kit (lot#: unknown).No injury to the patient occurred".The patient status is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).In section d provided the full udi # **udi related data quality updates only**.

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5 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: laura guadalupe gonzalez ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18401644
• Report Number: 3006425876-2023-01283
• Device Sequence Number: 11754036
• Product Code: DQY
• UDI-Device Identifier: 00801902102171
• UDI-Public: (01)00801902102171(11)220531(17)260930(10)71F22E7639(21)
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K862056
• 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: 09/30/2026
• Device Catalogue Number: CS-15854-E
• Device Lot Number: 71F22E7639
• 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: 12/04/2023
• Supplement Date Received by Manufacturer: 01/19/2024; Not provided
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 01/22/2024; 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2022
• 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