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: the sample was not returned for evaluation, one medical record was provided for review.The investigation is confirmed for the reported port flipped and blocked connection issue.According to the medical record, approximately two weeks post port placement, the left chest port was attempted to be accessed; however, this was unsuccessful.Subsequently, a spot radiograph of the chest revealed left that the catheter appeared to be intact and the left chest port was flipped sideways in the left chest pocket.Four days later, the patient¿s pre-operative diagnosis demonstrated poor and difficult intravascular access.Eventually the left chest port was removed and replaced with new single lumen port.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.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.
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