Model Number 0035280 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/04/2020 |
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.
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Event Description
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It was reported that the customer found prior to opening a package, that there was a foreign material inside it.Per follow up with the ibc via email on 17nov2020, we could not obtain the detail information of the place the foreign material was found.
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Event Description
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It was reported that upon opening a package the customer found a foreign material inside the package.Per follow up with the ibc via email on (b)(6) 2020 it was stated that the customer could not obtain the detailed information of the place where the foreign material was found.
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Manufacturer Narrative
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The reported event was confirmed.Visual inspection noted one unopened irrigation bulb syringe was received.Visual evaluation noted that there was a green fiber like loose piece of foreign material measuring 0.1095 inches found on the inside of the syringe barrel on return.A potential root cause for this failure mode was unable to determine.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Per investigation a labeling review was not required.H11: 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.H3 other text : the actual/suspected device was inspected.
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Search Alerts/Recalls
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