MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 8.5FR X 20CM; CATHETER,INTRAVASCULAR,THERAP

Catalog Number	CS-25853-E
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that " (doctor) was going to insert the cvc into the female patients left femoral vein.On inserting the needle into the femoral vein, that was connected to the raulerson syringe, he aspirated air and not blood from the vein.On closer inspection they realized the needle hub was cracked.They had to open another cvc pack and inserted the cvc into the left femoral vein without any incident." it was reported "patient was critical and needed a cvc and the incident caused a delay in treatment.".
Additional Manufacturer Narrative
(b)(4) the customer provided one photo for analysis.The photo displayed the 18ga introducer needle assembled over the arrow raulerson syringe (ars), and the needle hub contained evident cracking.The complaint of a cracked needle hub was able to be confirmed by the photo.The customer also returned one ars and 18ga introducer needle within an opened cvc kit.Definite evidence of use was observed on the needle cannula.The returned needle hub was broken and separated.The separation partially aligned with the mold seams of the needle hub.The separated portion of the hub was not returned for analysis.Multiple cracks were additionally observed on the intact portion of the hub.The needle was sent to the r & d facility to further investigate the issue.Material testing of the hub was performed, and it confirmed that the hub was composed of polycarbonate, which is consistent with a new hub design.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit contains the following warning for users: "some disinfectants used at catheter insertion site contain solvents which can weaken the catheter material.Alcohol, ac etone, and polyethylene glycol can weaken the structure of polyurethane materials.These agents' may also weaken the adhesive bond between catheter stabilization device and skin.Do not use acetone on catheter surface.Do not use alcohol to soak catheter surface or allow alcohol to dwell in a catheter lumen to restore catheter patency or as an infection prevention measure.Do not use polyethylene glycol containing ointments at insertion site.Take care when infusing drugs with a high concentration of alcohol.Allow insertion site to dry completely prior to skin puncture and before applying dressing.Do not allow kit components to come into contact with alcohol." the customer report of a broken and separated needle hub was confirmed by visual inspection of the customer supplied photo and sample received.Visual inspection revealed that the needle was cracked and broken.The needle was sent to the (b)(6) facility to further investigate the issue.At this point, the root cause cannot be determined based on the available information.Further investigation of the failure will be performed via a non-conformance.Teleflex will continue to monitor and trend on reports of this nature.
Event or Problem Description
It was reported that " (doctor) was going to insert the cvc into the female patients left femoral vein.On inserting the needle into the femoral vein, that was connected to the raulerson syringe, he aspirated air and not blood from the vein.On closer inspection they realized the needle hub was cracked.They had to open another cvc pack and inserted the cvc into the left femoral vein without any incident." it was reported "patient was critical and needed a cvc and the incident caused a delay in treatment.".

• Brand Name: ARROW CVC SET: 3-LUMEN 8.5FR X 20CM
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• 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: 20471920
• Report Number: 3006425876-2024-01000
• Device Sequence Number: 7228471
• Product Code: FOZ
• UDI-Device Identifier: 10801902146134
• UDI-Public: (01)10801902146134(11)231003(17)250912(10)71F23J1229(21)
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2024

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: 09/12/2025
• Device Catalogue Number: CS-25853-E
• Device Lot Number: 71F23J1229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2024
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2023
• 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 Age: 80 YR
• Patient Sex: Female