Catalog Number UNKNOWN |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/05/2024 |
Event Type
malfunction
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Manufacturer Narrative
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B3.The date received by manufacturer has been used for this field.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
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Event Description
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It was reported that unspecified bd infusion set was leaking the following information was received by the initial reporter with the following verbatim: there was a chemo spill at clinic today, thankfully a small amount.The leak was noticed at the end of a 2-hour infusion.According to the nurses, there were tiny holes in the tubing near the end.I wish they had taken pictures or kept the tubing- but given that it is hazardous, everything was discarded.I reviewed dispense prep pictures of the compound and visually tubing looks intact and there are no wet spots on the chemo mat at all.
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Event Description
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No additional info.
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Manufacturer Narrative
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No product or photo was returned by the customer.The customer complaint that there were tiny holes in the tubing near the end could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because the lot number is unknown.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.
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Search Alerts/Recalls
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