It was reported that bd alaris pca administration set disconnected.The following information was received by the initial reporter with the verbatim: "we have had four separate issues: first a disconnection from a patient, from the pca tubing, second and third, tubing had holes and cracks in it.Fourth a break in the tubing where it connects to the syringe".
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No new additional information: material#: 30883, batch number#: 22095083.It was reported by customer that they had four separate issues: first a disconnection from a patient, from the pca tubing, second and third, tubing had holes and cracks in it.Fourth a break in the tubing where it connects to the syringe.Verbatim# "we have had four separate issues: first a disconnection from a patient, from the pca tubing, second and third, tubing had holes and cracks in it.Fourth a break in the tubing where it connects to the syringe".Customer reply: confirm whether the four incidents happened in the same date.If not, please provide the dates separately.Happened on different dates, we work 12 hour shifts so times as estimates only: 12/5/23 @ 2300- pca micro bore tubing found disconnected from syringe, medication leaked onto floor.12/11/23 @ 0900- pca tubing micro bore tubing leaking medication on floor, defects found in pca small bore tubing.12/12/23 @ 2130 -pca tubing micro bore tubing leaking mediation on floor, defects found in pca small bore tubing.12/14/23 @ 0800-luer lock on pca syringe broke off from pca tubing.Describe any patient harm, injury, complication or negative outcome that occurred because of the event.No patient harm was found, other than having to waste a medication.Please confirm any sample or photo available for investigation.If yes, provide the address of the facility for us to ship the return label? i have samples stored away that can be sent back, i will get them today and send them to (b)(4) to get back to you.Did all the four events occurred in the same product.If not, please provide the details.Three events occurred with the pca tubing, another was with a syringe that connects to this same tubing as detailed in original message.
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