As the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.The catalog number identified has not been cleared in the us but is similar to the denali products that are cleared in the us.The pro code and 510 k number for the denali products are identified.Expiry date: 08/2023.
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H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the denali products that are cleared in the us.The pro code and 510 k number for the denali products are identified in d2 and g4.H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one denali filter kit dilator was returned for evaluation.During the visual evaluation, it was observed that the distal tip of the dilator was deformed.The dilator was flushed with water.The water came out from the tip of the dilator without issue.Therefore, the investigation is unconfirmed for the obstruction of flow issue as the water came out from the dilator without issue.However, the investigation is confirmed for the deformation of the distal tip of the dilator, as the distal tip was found to be damaged.One electronic photo was reviewed.The photo shows the distal part of the dilator.It looks like the tip of the dilator was found to be damaged.Although, the tip of the dilator was not clearly visible in the given photo.Therefore, based on the photo review, the reported obstruction of flow can not be confirmed.A definitive root cause for the reported obstruction of flow and identified deformation due to compressive stress issue could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 08/2023), g3, h6 (device, method) h11: h6 (result, conclusion) 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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