Model Number 306546 |
Device Problem
Partial Blockage (1065)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/03/2021 |
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 as a default.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that bd posiflush¿ iv flush solution sodium chloride had a difficult to move plunger.The following information was provided by the initial reporter: " it was reported that the plunger is stopping during injection.".
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Event Description
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It was reported that bd posiflush¿ iv flush solution sodium chloride had a difficult to move plunger.The following information was provided by the initial reporter: " it was reported that the plunger is stopping during injection ".
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Manufacturer Narrative
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H.6.Investigation: it was reported the plunger is stopping during the injection.As a sample was not returned, a thorough sample investigation could not be completed.It could be possible that the customer is getting some products that are towards the high specification limit and are related to the symptom reported by the customer since they require extra force than normal to expel the solution.A device history record review was completed for provided material 306546, lot number 1263323.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Based on the investigation and with no sample analysis the symptom reported by the customer could not be confirmed.H3 other text : see h.10.
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Search Alerts/Recalls
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