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

Model Number	IPN030921
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that incident occurred while repositioning the patient who was intubated and ventilated at the time.After rolling, i was removing the glide sheets that was underneath the patient.His central venous catheter (cvc) was in the right side of the neck at the time of the incident.There was one port on the cvc that was not connected to any infusions and while i was removing the slide sheets by pulling, the port must have become stuck in the glide sheet and the white port and bionector that was attached to the white port snapped off.I heard a loud pop and saw that there was now an open line on the cvc.Additional information was requested but was not available at the time of the report.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "incident occurred while repositioning the patient who was intubated and ventilated at the time.After rolling, i was removing the glide sheets that was underneath the patient.His central venous catheter (cvc) was in the right side of the neck at the time of the incident.There was one port on the cvc that was not connected to any infusions and while i was removing the slide sheets by pulling, the port must have become stuck in the glide sheet and the white port and bionector that was attached to the white port snapped off.I heard a loud pop and saw that there was now an open line on the cvc." additional information was requested but was not available at the time of the report.
Additional Manufacturer Narrative
(b)(4).The customer provided three photos for evaluation.The report of an extension line/luer hub separation was able to be confirmed by the photos.The customer also returned one 4-l cvc and one unopened cvc set for evaluation.Based on the sample received and clarification from the customer, the unopened kit is a representative sample.The returned catheter body was intentionally severed.Visual inspection of the catheter revealed the proximal extension line separated directly adjacent to the luer hub.A portion of the extension line was still molded into the luer hub.Microscopic examination confirmed the damage.The separation point appeared rough and jagged.Visual inspection of the returned representative kit revealed no obvious defects or anomalies.The proximal extension line outer diameter measured 2.17mm which is within the specifications of 2.13-2.21mm per product drawing.The proximal extension line inner diameter measured 1.4478mm which is within the specifications of 1.42-1.50mm per product drawing.This indicates that the extension line wall thickness measured within specifications.Functional inspection of the catheter was performed per the instructions for use (ifu) provided with the kit which states, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." the distal, medial 1, and medial 2 extension lines were flushed using a lab inventory 10ml syringe.No leaks or blockages were observed.A manual tug test confirmed the distal, medial 1, and medial 2 extension lines were secured to their respective luer hubs.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.The instructions for use (ifu) provided with this kit warns 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." the customer report of an extension line/luer hub separation was confirmed through complaint investigation of the returned sample.Visual inspection revealed the proximal extension line separated directly adjacent to the luer hub.A device history record review was performed based on a potential lot with no relevant findings.A capa has previously been initiated due to an increasing trend of cvc extension line leaks and separations.Corrective actions have not yet been implemented.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5FR X 16CM
• 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: 17758890
• Report Number: 3006425876-2023-00893
• Device Sequence Number: 6664632
• Product Code: FOZ
• UDI-Device Identifier: 10801902029345
• UDI-Public: 10801902029345
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K900263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2023

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
• Device Model Number: IPN030921
• Device Catalogue Number: CV-22854
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2023
• Supplement Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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