As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.Expiration date: (expiry date: (b)(4) 2024) 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.Device pending return.
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H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one unsealed x-port mri implantable port kit was returned for evaluation.Gross visual evaluation was performed.In addition to the returned physical sample, one electronic photo was provided for review.The photo review shows, one x-port mri implantable port attached to the catheter, ifus, id cards, implant record cards and contamination is observed throughout the septum of the implantable port and catheter body.During visual and manufacturing evaluation, water stains were noted throughout the back of the label and a small fibers were noted throughout the implantable port septum.Therefore, investigation is confirmed for the reported contamination issue.A definitive root cause could not be determined based upon the available 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: 04/2024), g3.H11: h6 (method, 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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