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Catalog Number MY8010 |
Device Problem
Complete Blockage (1094)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/29/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Date of birth: unknown.The patient¿s age was used to determine a placeholder date for this field.The initial reporter also notified the fda.Medwatch report # (b)(4).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 bd texium¿ needle-free syringe was blocked when attached to the spinal needle.Three attempts were made to inject without success.The following information was provided by the initial reporter: "patient was sedated for lumbar puncture with intrathecal chemotherapy.Lumbar puncture and csf collection completed without problem, attempted to attach it chemo syringe to hub of spinal needle, some flash of yellow methotrexate fluid noted, but once fully attached, could not infuse chemo, plunger would not budge.Removed, readjusted, and re-attached, still would not infuse.Removed again, spinal needle inspected by attending and csf noted to still be freely flowing.Third attempt also unsuccessful.".
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Event Description
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It was reported that the bd texium¿ needle-free syringe was blocked when attached to the spinal needle.Three attempts were made to inject without success.The following information was provided by the initial reporter: "patient was sedated for lumbar puncture with intrathecal chemotherapy.Lumbar puncture and csf collection completed without problem, attempted to attach it chemo syringe to hub of spinal needle, some flash of yellow methotrexate fluid noted, but once fully attached, could not infuse chemo, plunger would not budge.Removed, readjusted, and re-attached, still would not infuse.Removed again, spinal needle inspected by attending and csf noted to still be freely flowing.Third attempt also unsuccessful.".
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Manufacturer Narrative
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H6: investigation summary: no product or photo was returned by the customer.The customer complaint that the set would not infuse could not be verified due to the product not being returned for failure investigation.A device history record review for model my8010 lot number 92127202 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.
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Search Alerts/Recalls
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