Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: a complaint of tubing being cut in half and leaking was received from the customer.No product or photo was returned by the customer.The customer complaint of component damage could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because a model or lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
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It was reported that the unspecified bd¿ infusion set tubing was cut in half, causing cyclophosphamine to leak out after spiking the bag.The following information was provided by the initial reporter: "i was prepping cyclophosphamine to prime it into the tubing.I opened the tubing package close the roller clamp, spike the bag and unroll the tubing.As i was unrolling the tubing i notice the chemo spilling into the floor.I quickly clamp the tubing located at the beginning of the tubing.Then i noticed the tubing was cut in half.".
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