MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL CATH SET: 20 GA X 8CM; CATHETER, PERCUTANEOUS

Catalog Number	SAC-00820
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn (b)(4).
Event or Problem Description
It was reported that "the guidewire is not straight rather bent." there was no patient involvement.No patient harm or injury.
Event or Problem Description
It was reported that "the guidewire is not straight rather bent." there was no patient involvement.No patient harm or injury.
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided eight photos for analysis.Two photos show six unopened arterial kits.The remaining six photos show a close-up of kinking on the guide wires.Crease marks on the outer packaging and protective tubing were also observed around the location of the kinking.Per the lidstock artwork and the customer photos, kits of this type contain a "do not bend" warning on the front of the lidstock.A device history record review was performed, and no relevant findings were identified.The customer report of a guide wire kinked in the package was confirmed by visual inspection of the customer supplied photos.The guide wire, protective tubing, and packaging were kinked/creased.This is consistent with damage caused by shipping and handling.The words "do not bend" are printed on the front of the lidstock for this product.Based on these circumstances, storage and shipping likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.Corrected data: section d.4.- unique identifier (udi)# corrected from (b)(4).

• Brand Name: ARROW ARTERIAL CATH SET: 20 GA 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: 19444854
• Report Number: 3006425876-2024-00543
• Device Sequence Number: 19646709
• Product Code: DQY
• UDI-Device Identifier: 10801902144079
• UDI-Public: 10801902144079
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K093050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2024

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-00820
• Device Lot Number: 71F23D0009
• 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: 05/07/2024
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 06/02/2024
• Supplement Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2023
• 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