BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ SYRINGE; SALINE, VASCULAR ACCESS FLUSH
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Catalog Number 306594 |
Device Problem
Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/08/2022 |
Event Type
malfunction
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Manufacturer Narrative
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E.1 initial reporter phone #: (b)(6).H.6 investigation summary: a device history record review was completed by our quality engineer team for provided material number 306594 and lot number 1117209.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.There are quality controls currently in place to detect this type of defect during the production process.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.H3 other text : see h.10.
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Event Description
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It was reported that the bd posiflush¿ syringe was broken.The following information was provided by the initial reporter, translated from japanese to english: when preparing to open the disposable prefilled catheter flushing device for use, it was found that the front end was broken inside the cover.
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Search Alerts/Recalls
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