Model Number N/A |
Device Problems
Crack (1135); Fluid/Blood Leak (1250)
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Patient Problems
Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/25/2023 |
Event Type
malfunction
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Event Description
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Customer reported leaking at y-site hub connection with needlefree connector.Chemo leaked on patient.No other information was provided.
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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.The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The device has not been received by the manufacturer for evaluation.
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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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Customer reported leaking at y-site hub connection with needle-free connector and chemo leaked on patient.No other information was provided.Additional information received: treatment provided with hazardous drug/chemo exposure, some patients required de-access and re-access with port needle.Chemo/hazardous drug exposures.No visible damage reported.Hazardous drug/chemotherapy infusions and port accesses in blood draw areas.The procedure was completed as planned.But created hazardous drug/chemo exposure to patient, staff, and home health workers.
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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 port needles were removed from main blood draw for testing/investigation by the customer on (b)(6) 2023.Needles from lot asgufc098 were deemed faulty.There were no visible cracks in the hub of the port needle.No visible damage reported.
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Event Description
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It was reported port needles were removed from main blood draw for testing/investigation by the customer on (b)(6) 2023.Needles from lot asgufc098 were deemed faulty.There were no visible cracks in the hub of the port needle.No visible damage reported.
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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.The following investigation elements were determined to be applicable and were completed as part of this investigation: ¿ sample analysis based on a review of this information, the following was concluded: the complaint of a crack in the y-site was confirmed.The returned sample was found to exhibit the same features as a known issue.This complaint will be recorded for future trending and monitoring purposes.
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Search Alerts/Recalls
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