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: a sealed powerport mri implantable port kit was returned for evaluation.Visual evaluation was performed on the returned device.During visual evaluation, what appeared like an insect and unknown residue, was noted within the top portion of the glued patient discharged kit on the back of the package tray.Manufacturing site evaluation of the sample found yellow contamination is found outside the literature packaging.A closer look showed that the contamination appears to be waste caused by some kind of insect.This condition could be caused in the process of shipping the material.The investigation is confirmed for the reported bug inside the package issue.A definitive root cause is determined to be manufacturing related.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: 05/2024).H11: section a through f ¿ the information provide by bd represents all 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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