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Catalog Number 306572 |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/18/2023 |
Event Type
malfunction
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Event Description
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It was reported that bd posiflush syringe stopper separated from the plunger.The following information was provided by the initial reporter, translated from french to english: during an attempt to unblock an implantable chamber, the piston of se bd posiflush10ml got stuck in my hands: it dislodged from the membrane inside the syringe.Nothing for the patient at the time, but it could have happened.For me as a carer, i had to take another se, interrupt care; the same thing happened to a colleague this morning.
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Manufacturer Narrative
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H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
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Manufacturer Narrative
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A device history record review was completed for provided material number (b)(4) and lot number 3285240.The review did not reveal any possible non-conformances during the production process that could have contributed to this reported incident.As neither physical samples nor picture samples were available, a thorough sample analysis could not be completed at this time.Based on the investigation results, an exact cause could not be determined for this incident.This is the first report received for this type of defect on material (b)(4) and batch (b)(4).At this time, further action has not been determined necessary.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.H3 other text : see narrative below.
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Event Description
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No additional information.
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Search Alerts/Recalls
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