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It was reported that during preparation for the procedure, a viscous substance in the device was allegedly adhered to the physician's glove which made the shaft seemed uneven.It was further reported that the substance was wiped clean and the device seemed less uneven.It was further reported that another similar device was opened which also had the same viscous substance, so the physician completed the procedure using a different product.There was no patient contact.
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H10: manufacturing review: a complaint history review was performed.This is the fifth complaint reported for this lot number.The device history records were reviewed and there was nothing found to indicate there was a manufacturing related cause for these reports.Investigation summary: the sample was returned for evaluation and it was clean with no evidence of contamination.The device exhibited areas which were dull in appearance indicating some absence of hydrophilic coating.It was reported that the substance was wiped from the device.The result of the investigation is unconfirmed for the reported contamination issue.The definitive root cause for the reported contamination issue could not be determined based upon the available information.Labeling review: instructions for use for the halo one thin-walled guiding sheath was reviewed and the following sections are applicable: precautions: 6.Carefully inspect the sheath prior to use to verify that the sheath has not been damaged during shipment and that its size, shape and condition are suitable for the procedure for which it is to be used.Do not use if product damage is evident.Directions for use: equipment required: ¿ sterile saline solution (heparinized), ¿ sterile saline solution (heparinized) / contrast medium (2:1 ratio recommended), ¿ luer lock syringe/inflation device with manometer (10 ml or larger), ¿ 0.035" (0.89 mm) guidewire or 0.018" (0.46 mm) guidewire as labeled per device halo one thin-walled guiding sheath preparation.1.Verify the french size is suitable for the procedure and can accommodate the required procedural devices as labeled (figure 3).Remove sheath and dilator from package.2.Prior to use, the air in the sheath and dilator should be removed.To facilitate purging, the device is packaged with the dilator inside the sheath in a reverse direction allowing both to be flushed simultaneously.Select a syringe or inflation device with a 10 ml or larger capacity and fill approximately half of it with sterile saline solution.Prepare the lumen by connecting the syringe or inflation device containing the solution into the stopcock on the side-port of the sheath and flush with the sterile heparinized saline solution (figure 4).Close the stopcock to maintain the air tightness following flushing.3.Prior to use the reverse loaded dilator must be removed from the distal end of the sheath.If not already completed at step 2, the air in the dilator lumen should be removed.To facilitate purging, select a syringe or inflation device with a 10 ml or larger capacity and fill approximately half of it with sterile saline solution.Prepare the lumen by connecting the syringe or inflation device containing the solution into the luer connector of the dilator hub and flushing with the sterile heparinized saline solution (figure 7).4.Insert the provided vessel dilator through the hemostatic valve and click the dilator hub into place in the valve housing (figures 5 and 6).5.In order to activate the hydrophilic coating, where labeled, it is recommended to wet the halo one thin-walled guiding sheath with sterile saline solution immediately prior to its insertion in the body.H10: d4 (expiry date: 09/2022).H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text: see h10.
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It was reported that during preparation for the procedure, a viscous substance in the device was allegedly adhered to the physician's glove which made the shaft seemed uneven.It was further reported that the substance was wiped clean and the device seemed less uneven.It was further reported that another similar device was opened which also had the same viscous substance, so the physician completed the procedure using a different product.There was no patient contact.
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