MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL CATH SET: 22GA X 8CM; CATHETER PERCUTANEOUS

Catalog Number	SAC-00822-PBX
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when opening the arterial line catheter, the guidewire was found to be bent.The device was replaced.The patient had no harm or injury.
Additional Manufacturer Narrative
Qn #(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer provided two photos for analysis.The photos show an opened sac-00822-pbx kit with signs of folds and creases.The guide wire within the protective guard appeared kinked and was removed from the catheter.The customer also returned one, opened sac kit for evaluation.The returned packaging had signs of folding/creasing upon return.Visual analysis revealed the guide wire and protective tubing were kinked within the packaging.Visual analysis revealed the protective tubing had three kinks which aligned with the kinks on the guide wire.There was an additional kink at the proximal end of the guide wire that would have been within the catheter during full assembly.No defects or anomalies were observed on the catheter.The lidstock clearly states, "do not bend." the damage observed is consistent with defects related to storage and shipping.Microscopic examination confirmed the damage and confirmed the distal and proximal welds were secure and intact.The kinks on the guide wire measured 19 mm, 97 mm, 144 mm, and 172 mm from the proximal tip.The guide wire length measured 349 mm, which is within the specification limits of 345-355 mm per guide wire product drawing.The guide wire outer diameter measured 0.519 mm, which is within the specification limits of 0.508-0.533 mm per guide wire product drawing.The guide wire was functionally tested per the product instructions for use.The ifu provided with this kit instructs the user, "insert tip of guidewire through introducer needle into artery (until depth-marking [if provided] on wire enters hub of needle)." the guide wire was advanced through the returned introducer needle and the undamaged portions were able to pass with little to no resistance.A manual tug test confirmed that the distal and proximal welds were secure and intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit warns the user , "do not use if package is damaged." the lidstock was reviewed as part of this complaint investigation.The words "do not bend" are clearly visible on the front of the lidstock.The customer report of a kinked guide wire was confirmed through complaint investigation of the returned sample.Kinking was observed on the guide wire body which aligned with kinking on the protective tubing.The packaging had signs of folding/creasing upon return.The guide wire met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings.The packaging clearly states, "do not bend." based on the customer description and the samples received , storage and shipping caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that when opening the arterial line catheter, the guidewire was found to be bent.The device was replaced.The patient had no harm or injury.

• Brand Name: ARROW ARTERIAL CATH SET: 22GA X 8CM
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21719247
• Report Number: 3006425876-2025-00317
• Device Sequence Number: 15850705
• Product Code: DQY
• UDI-Device Identifier: 10801902129915
• UDI-Public: (01)10801902129915(11)240226(17)281231(10)71F23M0899(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K171146
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2025

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 Catalogue Number: SAC-00822-PBX
• Device Lot Number: 71F23M0899
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2025
• Supplement Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2024
• 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: Female