As reported, before use of a 65cm 1200psi catheter extension in the patient, the manifold (circled iron connector) was put out of the catheter tip which is "like a broken catheter tip".It seemed that they were not connecting tightly.There was no reported patient injury.Additional information received indicated that a total of nine (9) devices were opened.It was further clarified that those devices were used continuously and the hospital wanted to change the stock.Based on the product evaluation findings, the catheter extension was found broken.
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As reported, before use of a 65cm 1200psi catheter extension in the patient, the manifold (circled iron connector) was put out of the catheter tip which is" like a broken catheter tip".It seemed that they were not connecting tightly.There was no reported patient injury.Additional information received indicated that a total of nine (9) devices were opened.Case-(b)(6) during visual inspection, the unit was received with the insert cath ext broken and the retainer was found detached from the unit.Sem analysis on the broken portion of the catheter extension (insert) and presented evidence of fatigue striations and plastic deformation.A product history record (phr) review of lot 18079156 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The events reported by the customer ¿retainer (extension tubing only) ¿ detached¿ and ¿catheter extension ¿ separated¿ were confirmed for all nine of the returned devices.The catheter extension insert separated, which allowed the metal retainer to detach from the tubing.The fatigue striations and plastic deformations found on the material is commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the component was induced to a tensile force that exceeded the hub material yield strength prior to the separation.Handling factors such as rapidly jerking on the tubing may have contributed to the reported event.Users are trained to inspect for signs of damage prior to and during use.Any product with damage is not to be used.Information for safety is provided in the products labeling with the intent to make the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿to prevent damage, withdraw the catheter extension gently.Rapid removal or jerking may damage the extension.¿ based on the information available and the phr review, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.
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