Catalog Number 305272 |
Device Problems
Complete Blockage (1094); Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/24/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.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 integra¿ syringe with detachable needle was clogged and that caused a leak out the plunger.The following information was provided by the initial reporter: the customer reported that when they are injecting the medication, it is coming back up through the plunger instead of going through the needle.
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Manufacturer Narrative
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H6: investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.
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Event Description
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It was reported that the bd integra¿ syringe with detachable needle was clogged and that caused a leak out the plunger.The following information was provided by the initial reporter: the customer reported that when they are injecting the medication, it is coming back up through the plunger instead of going through the needle.
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Search Alerts/Recalls
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