MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC 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	05/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "sac catheter was kinked before use on patient." the returned device showed that the swg was kinked.
Event or Problem Description
It was reported that: "sac catheter was kinked before use on patient." the returned device showed that the swg was kinked.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one unopened sac kit for analysis.The kit was opened to further analyze the components.Visual inspection of the components revealed multiple kinks along the guide wire body.Additionally, bending of the guide wire tubing and several creases and folds on the product packaging were observed.The damage observed is consistent with defects related to storage and shipping.Both welds were present and appeared full and spherical.The packaging clearly states, "do not bend".The guide wire total length measured 349 mm which is within the specifications of 345-355mm per product drawing.The guide wire outer diameter measured 0.512 mm which is within the specifications of 0.508mm-0.533mm per product drawing.A manual tug test confirmed the distal and proximal welds were attached.A device history record review was performed with no relevant findings.The instructions for use (ifu) provided with this kit warns the user , "precaution: use of excessive force may damage catheter or guidewire.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 prior to use was confirmed through complaint investigation of the returned sample.Major bending of the guide wire tubing and several folds and creases on the outside packaging were also observed.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.
Additional Manufacturer Narrative
(b)(4) the customer returned one unopened sac kit for analysis.The kit was opened to further analyze the components.Visual inspection of the components revealed multiple kinks along the guide wire body.Additionally, bending of the guide wire tubing and several creases and folds on the product packaging were observed.The damage observed is consistent with defects related to storage and shipping.Both welds were present and appeared full and spherical.The packaging clearly states, "do not bend".The guide wire total length measured 349 mm which is within the specifications of 345-355mm per product drawing.The guide wire outer diameter measured 0.512 mm which is within the specifications of 0.508mm-0.533mm per product drawing.A manual tug test confirmed the distal and proximal welds were attached.A device history record review was performed with no relevant findings.The instructions for use (ifu) provided with this kit warns the user , "precaution: use of excessive force may damage catheter or guidewire.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 prior to use was confirmed through complaint investigation of the returned sample.Major bending of the guide wire tubing and several folds and creases on the outside packaging were also observed.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.Corrected data: section d.4.- unique identifier (udi)# corrected from (b)(4).
Event or Problem Description
It was reported that: "sac catheter was kinked before use on patient." the returned device showed that the swg was kinked.

• Brand Name: 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19508091
• Report Number: 3006425876-2024-00645
• Device Sequence Number: 12637016
• Product Code: DQY
• UDI-Device Identifier: 10801902144062
• UDI-Public: 10801902144062
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Followup
• Report Date (Section B): 05/17/2024

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 Expiration Date: 09/30/2026
• Device Catalogue Number: SAC-00520
• Device Lot Number: 71F21K2001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2024
• Supplement Date Received by Manufacturer: 06/20/2024; Not provided
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 06/26/2024; 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2021
• 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; NOT REPORTED
• Patient Sex: Unknown