Catalog Number 306594 |
Device Problem
Partial Blockage (1065)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/26/2021 |
Event Type
malfunction
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Event Description
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It was reported that the bd posiflush¿ syringe plunger was difficult to move during use.The following information was provided by the initial reporter, translated from (b)(6) to english: "the stopper of the flush won't move when giving the patient an indwelling needle".
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Manufacturer Narrative
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Investigation summary: a device history record review was completed by our quality engineer team for provided material number 306594 and lot number 0350983.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Further action has not been determined necessary at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
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Event Description
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It was reported that the bd posiflush¿ syringe plunger was difficult to move during use.The following information was provided by the initial reporter, translated from (b)(6) to english: "the stopper of the flush won't move when giving the patient an indwelling needle".
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Manufacturer Narrative
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Investigation summary: a device history record review was completed by our quality engineer team for provided material number 306594 and lot number 0350983.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Further action has not been determined necessary at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
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Search Alerts/Recalls
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