Model Number 383559 |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/22/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Unknown manufacturer: there are multiple bd locations where this bd device may have been manufactured.A lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.(b)(4).Medical device lot #: an invalid lot # of 1325661 was provided by the initial reporter.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.
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Event Description
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It was reported that the bd nexiva¿ closed iv catheter system with bd maxzero¿ needle-free connector experienced damaged tubing.The following information was provided by the initial reporter: the item was defective because the tubing broke while trying to enter the patient¿s arm.
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Manufacturer Narrative
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Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
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Event Description
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It was reported that the bd nexiva¿ closed iv catheter system with bd maxzero¿ needle-free connector experienced damaged tubing.The following information was provided by the initial reporter: the item was defective because the tubing broke while trying to enter the patient¿s arm.
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Search Alerts/Recalls
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