Catalog Number UNKNOWN |
Device Problem
Leak/Splash (1354)
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Patient Problem
Blood Loss (2597)
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Event Date 12/09/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.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.
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Event Description
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It was reported that the unspecified bd nexiva catheter experienced defective/damaged tubing which was noted during use.The following information was provided by the initial reporter: material no.: unknown batch no.: unknown.Per email: bd2 customer advocacy received a spreadsheet report from user facility on 19feb2020.Multiple attempts have been made to obtain additional information to no avail.Customer is also not sending any product back for investigation.Based on the customer's report, i believe the product in question is bd nexiva."patient's mom reported he was bleeding from his peripheral iv; found patient in bed with iv still connected and blood backing up from the catheter into the tubing and leaking out onto the patient and his bedding.Patient did not appear in any distress.Upon flushing the catheter, discovered a small hole had developed so that the iv fluids were no longer reaching the patient and blood was backflowing.Iv was immediately discontinued and patient was cleaned up; vast restarted iv in patient's foot.Defective tubing given to charge rn to take to safety huddle.".
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Manufacturer Narrative
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H.6.Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received. the lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.
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Event Description
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It was reported that the unspecified bd nexiva catheter experienced defective/damaged tubing which was noted during use.The following information was provided by the initial reporter: material no.: unknown, batch no.: unknown.Per email: bd2 customer advocacy received a spreadsheet report from user facility on 19feb2020.Multiple attempts have been made to obtain additional information to no avail.Customer is also not sending any product back for investigation.Based on the customer's report, i believe the product in question is bd nexiva."patient's mom reported he was bleeding from his peripheral iv; found patient in bed with iv still connected and blood backing up from the catheter into the tubing and leaking out onto the patient and his bedding.Patient did not appear in any distress.Upon flushing the catheter, discovered a small hole had developed so that the iv fluids were no longer reaching the patient and blood was backflowing.Iv was immediately discontinued and patient was cleaned up; vast restarted iv in patient's foot.Defective tubing given to charge rn to take to safety huddle.".
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Search Alerts/Recalls
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