Model Number N/A |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/14/2022 |
Event Type
malfunction
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Event Description
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It was reported there have been at least 4 events where the needle detaches from the wings when puncturing the port catheter.Additional information: the patients who are hospitalized in the oncology area witnessed the event and the nurses report that they did not pass any other medication that could cause greater damage.This report addresses the fourth device.
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Manufacturer Narrative
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The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refx0415 showed three other similar product complaint(s) from this lot number.The complaints for this lot number (refx0415) have been reported from the same facility in mexico.
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Manufacturer Narrative
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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.
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Event Description
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It was reported there have been at least 4 events where the needle detaches from the wings when puncturing the port catheter.Additional information: the patients who are hospitalized in the oncology area witnessed the event and the nurses report that they did not pass any other medication that could cause greater damage.This report addresses the fourth device.Additional information: the patients who are hospitalized in the oncology area witnessed the event with astonishment and the nurses report that fortunately they did not pass any other medication that could cause greater damage.Additional information received: in the hospital form it is reported that the needle completely detaches from the plastic, causing the solution to leak.There was no patient harm or need for medical intervention or events with skin/mucosal fluid exposure.The impact was that it is not possible to fully administer the drug and that there is also an increase in costs for the institution.
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Search Alerts/Recalls
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