Catalog Number 0935280 |
Device Problems
Device Contamination with Chemical or Other Material (2944); Physical Resistance/Sticking (4012)
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Patient Problems
No Consequences Or Impact To Patient (2199); 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 device was not returned.
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Event Description
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It was reported that the customer stated that there was something stuck inside of the syringe.
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Event Description
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It was reported that the customer stated that there was something stuck inside of the syringe.
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Manufacturer Narrative
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The reported event could not be confirmed as no sample was returned for evaluation.A potential failure mode could be ¿product with foreign material / hair; loose or embedded¿ with a potential root cause of ¿defective / contaminated components from supplier¿.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.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." section a through f - 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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Search Alerts/Recalls
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