Model Number 0935280 |
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 06/17/2021 |
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 pack with the bulb syringe appeared as condensation but had a slick and oily feel from the breast tray.Per follow up via email on (b)(6) 2021, the customer stated that the oily substance was found inside the device.
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Manufacturer Narrative
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The reported event was inconclusive as no sample was returned.A potential root cause for this failure could be due to "defective / contaminated components from supplier".It was unknown whether the device had met specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not performed because labelling could not have prevented the reported failure.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 device was not returned.
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Event Description
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It was reported that the pack with the bulb syringe appeared as condensation but had a slick and oily feel from the breast tray.Per follow up via email on (b)(6) 2021, the customer stated that the oily substance was found inside the device.
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Search Alerts/Recalls
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