MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL CATH SET: 20GA X 16CM; CATHETER,INTRAVASCULAR,THERAP

Catalog Number	SAC-01620
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The anaesthetist inserted the catheter into the femoral artery and had the normal flash back, inserted the wire through the needle, and then attempted to remove the needle.At this point, the yellow hub became disconnected from the needle but was enough outside the puncture site to be retrieved, fortunately.This was a reported by senior anaesthetic nurses who maintained that correct procedure for cannulation was followed.There was a reported delay but there was no reported patient harm.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided two photos for analysis.The complaint of needle cannula/hub separation was able to be confirmed by the second photo which shows the needle cannula separated from the needle hub.However, a complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit informs the user, "locate and puncture artery with desired introducer needle or introducer catheter/needle assembly, where provided.Pulsatile blood flow from the needle hub indicates successful entry into artery.Insert tip of guidewire through introducer needle into artery (until depth-marking [if provided] on wire enters hub of needle.Hold guidewire in place and remove introducer needle.Thread tip of catheter over guidewire.Grasping near skin, advance catheter into vessel." the customer stated, "the anesthetist inserted the catheter into the femoral artery and had the normal flash back, inserted the wire through the needle, and then attempted to remove the needle." it was confirmed with the customer that they had inserted the needle, followed by the wire, then the catheter.The customer report of needle cannula/hub separation was confirmed by visual inspection of the customer supplied photos.However, full 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 probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
The anaesthetist inserted the catheter into the femoral artery and had the normal flash back, inserted the wire through the needle, and then attempted to remove the needle.At this point, the yellow hub became disconnected from the needle but was enough outside the puncture site to be retrieved, fortunately.This was a reported by senior anaesthetic nurses who maintained that correct procedure for cannulation was followed.There was a reported delay but there was no reported patient harm.

• Brand Name: ARROW ARTERIAL CATH SET: 20GA 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: 18501326
• Report Number: 3006425876-2024-00069
• Device Sequence Number: 8087773
• Product Code: FOZ
• UDI-Device Identifier: 10801902144093
• UDI-Public: 10801902144093
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K002507
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 12/19/2023

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 Catalogue Number: SAC-01620
• Device Lot Number: 71F22H0047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2023
• Supplement Date Received by Manufacturer: 02/13/2024
• Initial Report FDA Received Date: 01/12/2024
• Supplement Report FDA Received Date: 02/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2022
• 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