Catalog Number 309210 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/12/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.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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Event Description
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It was reported that the tip/luer of the bd discardit¿ ii syringe had broken off and was missing.The following information was provided by the initial reporter: "cone of the syringe was missing.".
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Event Description
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It was reported that the tip/luer of the bd discardit¿ ii syringe had broken off and was missing.The following information was provided by the initial reporter: "cone of the syringe was missing,".
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Manufacturer Narrative
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H6: investigation summary a device history record review was completed for provided material number 309210 and lot number 2031729.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.As samples were unavailable for return, twenty retained samples were obtained for evaluation; however, no signs of defect were found.Although we were unable to confirm the reported incident for this record specifically, this type of defect has been previously confirmed for this lot number based on previous samples received.The material used to manufacture the discardit syringes has been selected and tested to resist normal conditions of use.The assembly machines have an inline detection system which inspects all product and automatically rejects any damaged product identified.This incident most likely resulted from a blockage during the barrel feeding process.After the blockage, the tip of the syringe was damaged and went undetected within the assembly machine.
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Search Alerts/Recalls
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