BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ NORMAL SALINE SYRINGE; SALINE, VASCULAR ACCESS FLUSH
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Catalog Number 306595 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/20/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H.6.Investigation summary: a device history record review was completed by our quality engineer team for provided material number 306595 and lot number 1256945.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 h10.
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Event Description
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It was reported that the bd posiflush¿ normal saline syringe leaked inside the packaging.The following information was provided by the initial reporter, translated from chinese: "on (b)(6) 2023, the nurse was preparing to seal a patient's tube for an infusion when she opened the package and found a wet rinse and suspected a leak.".
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