BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ SYRINGE; SALINE, VASCULAR ACCESS FLUSH
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Catalog Number 306594 |
Device Problems
Break (1069); Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/24/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that the luer of the bd posiflush¿ syringe was found broken.The following information was provided by the initial reporter, translated from chinese: "the patient came to our hospital for treatment of pneumonia, and at the end of the child's routine daytime sedation on (b)(6) 2023, when the nurse was preparing to seal the needle, she found that the pre-filled catheter flusher's anterior section of the rotating interface was broken, so she immediately discontinued the use of it and replaced it with a new pre-filled catheter flusher.".
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Event Description
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No additional information received.It was reported that the luer of the bd posiflush¿ syringe was found broken.The patient came to our hospital for treatment of pneumonia, and at the end of the child's routine daytime sedation on (b)(6) 2023, when the nurse was preparing to seal the needle, she found that the pre-filled catheter flusher's anterior section of the rotating interface was broken, so she immediately discontinued the use of it and replaced it with a new pre-filled catheter flusher.
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Manufacturer Narrative
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(b)(4) follow up: a device history record review was completed by our quality engineer team for provided material number 306594 and lot number 2087545.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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