Catalog Number UNKNOWN |
Device Problems
Leak/Splash (1354); Failure to Deliver (2338)
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Patient Problem
No Information (3190)
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Event Date 12/02/2020 |
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 (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used.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 posiflush¿ syringes had issues with difficult plunger movement and damaged stoppers.The following information was provided by the initial reporter: "it was reported via posiflush pmcf survey that the clinician experienced embolism, dysgeusia, damaged packaging, plunger movement difficulty and damaged syringe stopper within the past 12 months.".
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Manufacturer Narrative
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H.6.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.A capa is not required at this time.
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Event Description
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It was reported that the unspecified bd posiflush¿ syringes had issues with difficult plunger movement and damaged stoppers.The following information was provided by the initial reporter: "it was reported via posiflush pmcf survey that the clinician experienced embolism, dysgeusia, damaged packaging, plunger movement difficulty and damaged syringe stopper within the past 12 months.".
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Search Alerts/Recalls
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