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.The device has not been returned to the manufacturer for evaluation.
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It was reported, ¿a leak was observed in the tubing at the clamp (as if the clamp had been bent and pierced the tubing).The midline was removed, and another insertion was carried out." additional information received on 26-dec-2023: the patient impact was that they had to return to the hospital in a hurry to remove the midline and undergo a new insertion because their treatment had not been completed.
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