Catalog Number 307736 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/21/2022 |
Event Type
malfunction
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Event Description
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It was reported that propofol leaked past the bd emerald¿ syringe plunger stopper during use.The following information was provided by the initial reporter: "leakage of syringe where propofol (very potent medicine) has run back next to the rubber plunger.No personal- or patient injury.".
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Manufacturer Narrative
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A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Manufacturer Narrative
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The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 27-oct-2022.H6: investigation summary a device history record review was completed for provided material number 307736 and lot number 2205241.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.To aid in the investigation of this issue, the affected sample was returned for evaluation by our quality engineer team.Through examination of the sample, the syringe barrel was observed broken.Although the exact cause of breakage could not be determined, it has been concluded that the barrel damage resulted from an error during the assembly process.
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Event Description
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It was reported that propofol leaked past the bd emerald¿ syringe plunger stopper during use.The following information was provided by the initial reporter: "leakage of syringe where propofol (very potent medicine) has run back next to the rubber plunger.No personal- or patient injury.".
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Search Alerts/Recalls
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