Catalog Number 0935280 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problems
No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Event Description
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It was reported that particles were found inside and around the syringe.
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Manufacturer Narrative
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Although the reported event was confirmed, a root cause could not be determined.The inspector received four irrigation syringes with no packaging.The first sample had a yellowish material on the bulb.One had no visual defects or foreign material.Another had a black smear located on the bulb, and the final sample had two black smears on the bulb.The yellow smear on the first sample was measured to be 0.3645 inches in length and the third sample's black smear was measured to be 0.1190 inches in length.A potential root cause for this failure could be "defective / contaminated components from supplier." the device history record was reviewed and found nothing that could have caused or contributed to the reported event.21 cfr section 801.116 outlines the conditions upon which a device is exempt from adequate directions as follows: "sec.801.116 medical devices having commonly known directions: a device shall be exempt from section 502(f)(1) of the act insofar as adequate directions for common uses thereof are known to the ordinary individual." product catalog number 0935280 is deemed by appropriate subject matter experts (sme) to be within this definition.
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Event Description
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It was reported that particles were found inside and around the syringe.
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Search Alerts/Recalls
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