Catalog Number 8881135609 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/15/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H3.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 bd mon syringe barrel assembly had foreign matter.The following information was received by the initial reporter with the verbatim:
they discovered a monoject syringe with a brown particle stuck in the syringe wall.
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Event Description
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No additional information.
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Manufacturer Narrative
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Pr (b)(4) - follow up mdr for device evaluation.The customer reported a brown particle in the wall of the syringe, and returned the sample.The sample was visually inspected, and the complaint of foreign matter was verified.There is a foreign body within the syringe wall near the 10 ml mark.The photo of the issue was forwarded to the syringe supplier, and they confirmed the failure.The supplier conducted the device history record review with material#: 8881135609 and batch#: 2213015864 which showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.There was no official root cause able to be found for the issue, but a potential root cause is that the manufacturing or quality processes were not followed correctly.An awareness notification was sent to production personnel regarding this foreign matter issue.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.
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Search Alerts/Recalls
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