MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 4-LUMEN 8.5FR X 16CM; CATHETER, PERCUTANEOUS

Model Number	IPN918726
Medical Device Problem Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "in the last 2 months, when inserting the cvc, doctors have noticed that the dilator splits during the insertion of the dilator and this leads to difficult manipulation of the lead, sometimes even breaking it." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "unknown".
Additional Manufacturer Narrative
(b)(4).The customer returned one dilator for analysis.No definite signs-of-use were observed.Visual analysis revealed that dilator tip was widened.Microscopic examination confirmed the damage and revealed white stress marks.The dilator length measured 100mm, which is within the specification per the dilator product drawing.The dilator outer diameter measured 2.98mm, which is within the specification per the dilator extrusion product drawing.The dilator inner diameter at the distal tip measured 0.9398mm (0.037"), which is within the specification per the dilator extrusion product drawing.A lab inventory guide wire with diameter of 0.032" was inserted through the returned dilator tip.Despite the damage to the dilator tip, the guide wire was able to pass.Slight resistance was encountered at the dilator tip; however, the guide wire was able to pass.Performed per ifu statement, "use tissue dilator to enlarge tissue tract to the vein as required.Follow the angle of the guidewire slowly through the skin".R & d and manufacturing have been consulted regarding investigations of this nature.They stated that various factors could contribute to the observed damage to the dilator tip, including the manufacturing process and/or undue force applied unintentionally by the user.Due to the possibility that manufacturing contributed to this damage, they will further investigate this issue.The dilator product drawing and the dilator extrusion product drawing were reviewed as part of this complaint investigation.The ifu provided with the kit informs the user, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage".The report of a damaged dilator tip was confirmed through complaint investigation.Visual analysis revealed that the dilator tip was split/frayed.Despite the damage, all relevant dimensional and functional requirements were met, and a device history record review did not reveal any relevant findings.Based on the customer report, the sample received, and the comments from r & d, the root cause has not been determined at this time.Non-conformance was initiated so that the manufacturing facility can further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "in the last 2 months, when inserting the cvc, doctors have noticed that the dilator splits during the insertion of the dilator and this leads to difficult manipulation of the lead, sometimes even breaking it." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "unknown".

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5FR X 16CM
• 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: azhwan barazenda ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19722240
• Report Number: 3006425876-2024-00700
• Device Sequence Number: 8033496
• Product Code: DQY
• UDI-Device Identifier: 10801902029239
• UDI-Public: (01)10801902029239(11)230727(17)280531(10)71F24C0298(21)
• Combination Product (Y/N): N
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2024

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 Model Number: IPN918726
• Device Catalogue Number: CV-12854
• Device Lot Number: 71F24C0298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2024
• Supplement Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2023
• 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: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown