It was reported that post port device implant, the port was allegedly unable to infuse and as a result the lung was noted to be collapsed and punctured.Upon removal of the device, the device was found to be fractured and as a result embolized the heart.The current status of the patient is unknown.
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H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the sample was not returned for evaluation, one medical record was provided for review.The investigation is inconclusive for the reported malposition issue as the exact circumstances at the time of reported event was unknown.However, the investigation is confirmed for the reported pneumothorax issue.According to the medical record, a new 6.6-french single-lumen broviac catheter was tunneled, and the line again was then flushed with saline and ultimately with 5ml of heparin 10 units/ml.On the same day the patient presents with right pneumothorax with intrathoracic line placement.An 8.5 fr pigtail catheter was placed in chest tube for drainage of his lung.Subsequently the prior central line catheter was removed.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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