It was reported that twenty eight days post chronic catheter placement procedure, the catheter allegedly spontaneously presented bubbles, while the patient had already turned off parenteral nutrition and washed the catheter according to the protocol.It was further reported that it remained with ebb and flow, but when infused again it allegedly broke.There was no reported patient injury.
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Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one broviac s/l catheter was returned for evaluation.Gross, microscopic visual, tactile evaluation, destructive and functional testing were performed.A fracture was noted on the proximal portion of the inner catheter within the clamping sleeve.Upon infusion, a leak was observed from the inner catheter within the clamping sleeve.Therefore the investigation is confirmed for the reported fracture issue.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.D4 (expiry date: 01/2024).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.
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It was reported that twenty eight days post chronic catheter placement procedure, the catheter allegedly spontaneously presented bubbles, the patient had already turned off parenteral nutrition and washed the catheter according to the protocol.It was further reported that upon infusion the device allegedly broke.There was no reported patient injury.
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