H10: the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.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 jugular filter kit was returned for evaluation.Received components are pusher catheter, touhy-borst adapter, filter storage tube, filter, dilator, and introducer sheath.The filter was inside the storage tube.The pusher catheter was still inserted within the touhy adapter.The filter hook was noted to be dislodged from the pusher catheter gripper within the storage tube.The dilator arrived loaded into the introducer sheath.Damage was also noted to the distal tip of the dilator.Therefore, the investigation is confirmed for the device dislodged or dislocated as the filter hook was disengaged from the pusher gripper inside the storage tube.The investigation also confirmed for deformation due to compressive stress as the distal tip of the dilator was found to be damaged.A definitive root cause for the reported device dislodged or dislocated issue 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: 06/2024), g3.H11: b5, h6 (device, 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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