Catalog Number 306572 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/17/2019 |
Event Type
malfunction
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Manufacturer Narrative
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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 an unspecified number of bd posiflush¿ xs pre-filled flush syringes nacl 0.9% experienced leakage during use.The following information was provided by the initial reporter: pre-filled syringe leaking on induction.Syringe contents leaking under pressure.Minimal consequence apart from the inefficiency of pulsed flushing, risk of occlusion of the central passages or implantable chambers.
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Manufacturer Narrative
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H.6.Investigation summary: a thorough sample investigation could not be completed at this time.If the samples become available, a sample investigation will be completed if determined necessary.A device history record review was performed for lot number 9094918 and the review revealed an intermittent issue with the tip cap torque during the production process.The issue was resolved at this time of occurrence and product was held for inspection.All affected material should have been scrapped.It is possible that there may have been a limited occurrence of this defect outside of the contained material.At this time, further action has not been determined necessary.Our quality team will continue to monitor the production process for signs of this potential defect and any emerging trends.H3 other text : see h.10.
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Event Description
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It was reported that an unspecified number of bd posiflush¿ xs pre-filled flush syringes nacl 0.9% experienced leakage during use.The following information was provided by the initial reporter: pre-filled syringe leaking on induction.Syringe contents leaking under pressure.Minimal consequence apart from the inefficiency of pulsed flushing, risk of occlusion of the central passages or implantable chambers.
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Search Alerts/Recalls
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