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	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#( b)(4).
Event or Problem Description
It was reported that: bent catheter inside the box.Defect found during product inspection and labeling.Inspection of the returned device shows that the swg was kinked, making complaint reportable.There was no patient involved.
Event or Problem Description
It was reported that: bent catheter inside the box.Defect found during product inspection and labeling.Inspection of the returned device shows that the swg was kinked, making complaint reportable.There was no patient involved.
Additional Manufacturer Narrative
(b)(4).The customer report of a kinked guide wire prior to use was not confirmed through complaint investigation of the returned sample.Ho wever, significant kinking was observed on the protective tubing.In addition, several folds and creases were observed on the outside packaging.The guide wire met all relevant dimensional requirements, and a device history record review was performed with no relevant findings.The lidstock clearly states "do not bend." based on the customer description and the sample received, storage and shipping caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported that: bent catheter inside the box.Defect found during product inspection and labeling.Inspection of the returned device shows that the swg was kinked, making complaint reportable.There was no patient involved.
Additional Manufacturer Narrative
(b)(4).In section d provided the full udi # **udi related data quality updates only**.Other remarks: n/a.Corrected data: n/a.

• 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: laura guadalupe gonzalez ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18255450
• Report Number: 3006425876-2023-01188
• Device Sequence Number: 15098517
• Product Code: DQY
• UDI-Device Identifier: 10801902144062
• UDI-Public: (01)10801902144062(11)220203(17)270131(10)71F22A2848(21)
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K093050
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/01/2023

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-00520
• Device Lot Number: 71F22A2848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2023
• Supplement Date Received by Manufacturer: 01/09/2024; Not provided
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 01/09/2024; 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2022
• 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
• Patient Sex: Unknown