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.H3 other text : device not received.
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It was reported that when peeling the dilator, the dilator did not separate correctly into two parts around the catheter.Part of the dilator remained around the catheter and had to be incised with a scalpel in order to be removed, at the risk of breaching the catheter.No other information was provided.Additional information provided 11/30/2023: the event took place on 08/11/2023 and did not result in a serious injury or change in treatment.Medical procedure: scalpel incision of dilator.
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