BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH SYRINGE; SALINE, VASCULAR ACCESS FLUSH
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Catalog Number 306594 |
Device Problem
Crack (1135)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/10/2022 |
Event Type
malfunction
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Manufacturer Narrative
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A device history record review was completed by our quality engineer team for provided material number 306594 and lot number 1117469.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.Based on the investigation and with no sample analysis the symptom reported by the customer could not be confirmed.We will continue monitoring the complaint trend for this product and symptom.With no sample analysis a probable root cause could not be offered.
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Event Description
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It was reported while using bd posiflush syringe the plunger rod was damaged.There was no report of patient impact.The following information was provided by the initial reporter: when the nurse was preparing to flush the patient with an indwelling needle, he checked the 5ml flush and found that the syringe needle handle had a crack that affected flushing, and the prefilled catheter flusher should be replaced immediately.
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