Catalog Number 383572 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/05/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Bd nexiva 22ga x 1.00 in dp with maxzero.
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Event Description
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It was reported that bd nexiva 22ga x 1.00 in dp with maxzero had foreign matter.It was reported by the customer that plastic casing integrity was cloudy & in question.Verbatim: rcc received a complaint via email.Email(s) attached.Plastic casing integrity was cloudy & in question.Catheter, intravascular, therapeutic, short-term less than 30 days.
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Event Description
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Response received.1.Are you able to provide corrected batch / lot information reported? 3122730.2.How was the patient outcome? are there any clinical signs, health consequences or impact? no impact.
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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 383572 and lot number 3122730.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.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.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.
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Search Alerts/Recalls
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