MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3L 5.5 FR X 30 CM; CATHETER PERCUTANEOUS

Model Number	IPN918838
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "during a blood transfusion, blood backflow from the proximal to the distal side and vice versa occurred during bolus flushing." the catheter was inserted at femoral site.The catheter was removed and a new catheter inserted.It was reported there was no patient injury, complication, or delay in therapy.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer report of catheter backflow was confirmed through complaint investigation of the returned sample.The customer returned one opened cvc set including a 3-l catheter for evaluation.Evidence of use was observed on the catheter.Initial visual inspection of the catheter revealed no obvious defects or anomalies.After the catheter failed functional testing, it was cut to observe the extrusion.No obvious defects were observed within the extrusion.The catheter total length measured 12 1/2" via calibrated ruler, which is within the specifications of 12 1/32"-12 9/16" per product drawing.Functional inspection of the returned catheter was performed per the ifu provided with this kit, which states "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." with the catheter body occluded, the distal extension line was flushed using a lab inventory 10ml syringe.Water was observed exiting the proximal lumen through the luer hub.Similarly, when flushing the proximal extension line, water was observed exiting the distal lumen via the luer hub.No leaks or blockages were observed when flushing either extension line with the distal end uncapped.No defects were observed when flushing the medial extension line.A long pin gauge was inserted through the distal and proximal lumens.No blockages were observed.The pin gauge was able to exit through the appropriate exit port.The manufacturing facility indicated that this was a known manufacturing defect known as a gross leak failure.Additionally, the instructions-for-use (ifu) provided with this kit warns the user, "ensure catheter patency prior to use.Do not use syringes smaller than 10 ml to reduce risk of intraluminal leakage or catheter rupture." a device history record review was performed with no relevant findings.Based on these circumstances, and the comments from manufacturing, the probable root cause for this event was manufacturing related.Further investigation has been initiated under teleflex's quality system by the manufacturing site to further investigate this issue.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported "during a blood transfusion, blood backflow from the proximal to the distal side and vice versa occurred during bolus flushing." the catheter was inserted at femoral site.The catheter was removed and a new catheter inserted.It was reported there was no patient injury, complication, or delay in therapy.The patient's condition is reported as fine.

• Brand Name: ARROW CVC SET: 3L 5.5 FR X 30 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17213270
• Report Number: 3006425876-2023-00602
• Device Sequence Number: 12557038
• Product Code: DQY
• UDI-Device Identifier: 30801923122944
• UDI-Public: 30801923122944
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2023

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 Model Number: IPN918838
• Device Catalogue Number: CS-14553
• Device Lot Number: 71F23C1592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2023
• Supplement Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 06/27/2023
• Supplement Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2023
• 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: BLOOD TRANSFUSION; BLOOD TRANSFUSION
• Patient Age: 2 YR
• Patient Sex: Female
• Patient Weight: 11 KG