Catalog Number UNKNOWN |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/16/2020 |
Event Type
malfunction
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Manufacturer Narrative
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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 franklin lakes, nj has been listed and the franklin lakes fda registration number has been used for the manufacture report number.Medical 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.(b)(4).
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Event Description
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It was reported that the unspecified bd phaseal¿ optima injector (n35-o) leaked during use.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "pharmacy tech noticed red on outside of c-100 membrane after using doxo drug.Red was also found on the membrane of the n35 that was attached to the first syringe.".
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Event Description
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It was reported that the unspecified bd phaseal¿ optima injector (n35-o) leaked during use.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "pharmacy tech noticed red on outside of c-100 membrane after using doxo drug.Red was also found on the membrane of the n35 that was attached to the first syringe.".
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Manufacturer Narrative
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H6: investigation summary: no photos or physical samples that display the reported condition were available for investigation.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device.As the lot involved in this incident is unknown, a device history review cannot be performed and additional retained samples cannot be evaluated.Based on the available information we are not able to identify a root cause at this time.
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Search Alerts/Recalls
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