MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7FR X 20CM; CATHETER,INTRAVASCULAR,THERAP

Model Number	IPN916439
Medical Device Problem Codes	Unraveled Material (1664); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "after visual verification of the integrity of the device they proceeded to puncture the right internal jugular vein.With ra.Ce.Va, the non-exit of the guide from the needle has been detected.At the attempt to remove the guide, resistance is felt, then the needle is carefully retracted together with the guide from the vessel, and compression is performed.Analysis of the device shows the guide wedged in the needle.Then it comes off the needle and you notice the fraying / unwinding of the thread." no patient harm reported.Another catheter was used and inserted in the left jugular vein.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
It was reported that "after visual verification of the integrity of the device they proceeded to puncture the right internal jugular vein.With ra.Ce.Va, the non-exit of the guide from the needle has been detected.At the attempt to remove the guide, resistance is felt, then the needle is carefully retracted together with the guide from the vessel, and compression is performed.Analysis of the device shows the guide wedged in the needle.Then it comes off the needle and you notice the fraying / unwinding of the thread." no patient harm reported.Another catheter was used and inserted in the left jugular vein.The patient's condition is reported as fine.

• Brand Name: ARROW CVC SET: 3-LUMEN 7FR 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: 15741173
• Report Number: 3006425876-2022-00939
• Device Sequence Number: 2868525
• Product Code: FOZ
• UDI-Device Identifier: 10801902165913
• UDI-Public: 10801902165913
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 10/13/2022

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 Expiration Date: 02/29/2024
• Device Model Number: IPN916439
• Device Catalogue Number: CV-25703-E
• Device Lot Number: 71F22C2073
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2022
• Supplement Date Received by Manufacturer: 12/01/2022
• Initial Report FDA Received Date: 11/06/2022
• Supplement Report FDA Received Date: 12/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2022
• 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: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown