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, photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 04/2023).
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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 powerport titanium isp implantable port kit was returned for evaluation.Gross visual evaluation was performed.Although the sample was returned for evaluation, four electronic photos were provided for review.The investigation is confirmed for the reported contamination issue, as a piece of hair was noted to expose under the valve cap of the 8.0fr peel-apart sheath.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: 04/2023), 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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