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	02/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that " we found the product and packaging damaged crushed inside the box during the receipt and labeling inspection".This occured prior to use during inspection.
Additional Manufacturer Narrative
(b)(4).The customer provided one photo for evaluation.Reference picture1.The photo displayed multiple arterial kits, circling the kinking observed on the packaging and guide wire assemblies.The customer returned one unopened sac kit for analysis.The kit was opened to further analyze the components.Visual inspection of the components revealed one kink in the guide wire body.Several creases and folds were observed on the product packaging and guide wire tubing.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 major kink in the guide wire measured 26 mm from the distal end.The guide wire total length measured 350 mm which is within the specifications of 345-355mm.The guide wire outer diameter (od) measured 0.51 mm which is within the specifications of 0.508mm-0.533mm.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.Engineering change order-(b)(4) was implemented in (b)(6) 2017 to update the product labeling to clearly inform the customer to not bend the product and is intended to reduce the potential for product damage.This product was m anufactured (feb 2022) after the implementation date of the eco.The lidstock clearly states, "do not bend." corrective action is not required at this time as the probable root cause is storage and shipping related.The customer report of a kinked guide wire prior to use was confirmed through complaint investigation of the returned sample.One kink was observed on the guide wire body.In addition, several folds and creases were observed on the outside packaging and guide wire tubing.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.

• 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: keona jones ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18920393
• Report Number: 3006425876-2024-00244
• Device Sequence Number: 20730200
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/22/2024

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: 02/27/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: NONE REPORTED
• Patient Sex: Unknown