MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL CATH SET: 20 GA X 5CM; CATHETER, PERCUTANEOUS

Catalog Number	SAC-00520
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported " according to a medical report, when opening the packaging of the radial arterial catheter, it was found to be completely tortuous, invalidating its use".This was found prior to use.No patient harm or injury.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported " according to a medical report, when opening the packaging of the radial arterial catheter, it was found to be completely tortuous, invalidating its use".This was found prior to use.No patient harm or injury.
Additional Manufacturer Narrative
(b)(4).The customer provided two photos for analysis.The photos show a creased, opened sac kit with a kinked guide wire.The package shown in the photo clearly states "do not bend." thus, the complaint of a kinked guide wire was able to be confirmed by the photos, however, a complete visual inspection could not be performed as no sample was returned for analysis.The customer report of a kinked guide wire was confirmed by visual inspection of the customer supplied photo.The images show an opened arterial set with a kinked guide wire; 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.Corrected data: correction d.4 from (b)(4).

• Brand Name: ARROW ARTERIAL CATH SET: 20 GA X 5CM
• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19466607
• Report Number: 3006425876-2024-00565
• Device Sequence Number: 20688989
• Product Code: DQY
• UDI-Device Identifier: 10801902144062
• UDI-Public: 10801902144062
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K093050
• 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): 05/10/2024

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
• Device Catalogue Number: SAC-00520
• Device Lot Number: 71F22H0356
• 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: 05/10/2024
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 06/05/2024
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2022
• 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: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown