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It was reported that bd alaris pump module smartsite low sorbing infusion set had flow issues and leaking the following information was received by the initial reporter with the following verbatim: we had another incident where iv tubing was leaking.We have removed the tubing and want to send to the manufacturer.Could you please advise on the process.We had a defective set (see below).The ref # is (b)(4).The lot # is (10)23150138.Please let us know wat you need from us.Additional information received any adverse event or serious injury reported to patient or healthcare professional? 2 events of bd lot # (10)23150138 large infusion tubing leaking one patient had a picc line that clotted off and required removal and subsequent iv placement second patient: the rn noted drops of iv fluid dripping onto the floor.The tubing was immediately changed out.No known harm to the patient was there a delay of, or change in, the course of treatment due to the event? yes, see above, neonatal picc become clotted and required removal and subsequent iv placement any sample or photo available for investigation? yes see attached how was the patient outcome? are there any clinical signs, health consequences or impact? patient required a septic workup due to risk of infection how was treatment completed for customer? i¿m not sure what this question is asking patient status? multiple new peripheral ivs have been required.Family decline new picc line after the last one required removal any picture of this complaint see attached re: one of the tubing that was leaking 8.Please explain elaborate issue? a.Filter was noted to be wet ~0600 after tubing was changed the evening prior (approximately 9 hour prior).9.Date of event? 1/26/24 and 1/29/24.10.Physical available/not available? yes both tubings are available.12.Customer address? (b)(6).
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