Device Problem
Restricted Flow rate (1248)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/22/2022 |
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 patient had noted a small amount of straw-colored drainage and had gallbladder surgery one week ago.Patient was concerned there might be a blockage inside the body (material# 100cc evacuator, material#: 400cc evacuator).Bd representative explained how sometimes wound drains did get clogged with biological material.If it was visible in the tubing, they might try to milk the drain.It was also possible that they were healing and not making as much drainage and suggested doing nothing for the time being and waiting for their surgeon's follow-up.
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Event Description
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It was reported that the patient had noted a small amount of straw-colored drainage and had gallbladder surgery one week ago.Patient was concerned there might be a blockage inside the body (material# 100cc evacuator, material# 400cc evacuator).Bd representative explained how sometimes wound drains did get clogged with biological material.If it was visible in the tubing, they might try to milk the drain.It was also possible that they were healing and not making as much drainage and suggested doing nothing for the time being and waiting for their surgeon's follow-up.
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Manufacturer Narrative
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The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be due to "channels kinked or collapsed during use".It was unknown whether the device had met relevant specifications.It was unknown whether the product had caused the reported failure.The device history record review could not be performed without a lot number.The product catalog number and the lot number for this device are unknown.Therefore, bd is unable to determine the associated labeling to review.H11: section a through f - the information provided by bd represents all 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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Search Alerts/Recalls
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