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

Catalog Number	SAC-00520
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that " during the receipt and labeling inspection, we found the product with damaged packaging (crushed) inside the box".The photo shows that the swg is kinked.Associated complaints 3006425876-2024-00580.
Additional Manufacturer Narrative
(b)(4).The customer provided one photo for evaluation.The photo shows two unopened sac kits with creasing in the packaging and the appearance of kinked guide wires.The customer returned one, unopened sac kit for evaluation.The kit was opened to further inspect the returned components.Visual inspection of the returned guide wire revealed no kinking in its body.However, creasing was observed on the guide wire protective tubing and the kit packaging.Microscopic examination con-firmed the damage.Both welds were present and appeared full and spherical.The damage observed is consistent with defects related to storage and shipping.The lidstock clearly states "do not bend".The guide wire total length measured 349mm which is within the specifications of 345mm-355mm per product drawing.The guide wire outer diameter (od) measured 0.51mm which is within the specifications of 0.508mm-0.533mm per product drawing.Functional inspection of the guide wire was performed per the instructions-for-use (ifu) provided with the kit which states, "insert desired tip of spring-wire guide through introducer needle into artery (until depth-marking [if provided] on wire enters hub of needle).Thread tip of indwelling catheter over spring-wire guide." the undamaged portions of the guide wire were threaded through a lab inventory 20 ga introducer needle with no resistance.A manual tug test confirmed the distal and proximal welds were attached.The manufacturing site was previously consulted regarding the observed failure mode for related complaints.They indicated that the observed kink, in addition to the creasing in the packaging, is consistent with damage caused by shipping and handling.As part of the guide wire manufacturing process, each guidewire is passed through a ring gauge so it is unlikely that this defect would have been present prior to release from the manufacturing site.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 customer report of a kinked guide wire prior to use was confirmed through complaint investigation of the returned sample.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 " during the receipt and labeling inspection, we found the product with damaged packaging (crushed) inside the box".The photo shows that the swg is kinked.
Additional Manufacturer Narrative
(b)(4).

• 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19507894
• Report Number: 3006425876-2024-00569
• Device Sequence Number: 17998073
• 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): 05/17/2024

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 Catalogue Number: SAC-00520
• Device Lot Number: 71F22B1289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2024
• 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: 06/11/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2022
• 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: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown