H10: as this malfunction is considered one event; only one mdr report will be submitted for the reported quantity affected of 23 for this event.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: twenty two powerport isp implantable port kits were returned for evaluation.Gross visual evaluation was performed.However, two electronic photos were provided for review.The investigation is confirmed for the reported component misassembled issue, as each powerport isp implantable ports within the kits were noted to have bumps throughout the port septum.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 (expiration date: 04/2023), h11: g1, 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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