Model Number 309657 |
Device Problem
Leak/Splash (1354)
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Patient Problem
Insufficient Information (4580)
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Event Date 05/03/2023 |
Event Type
malfunction
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Event Description
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It was reported that the bd luer-lok¿ tip disposable syringe leaked the following information was provided by the initial reporter: dose of vancomycin was scanned and placed on medfusion pump, programmed through library.During administration, liquid noted to be dripping from pump and small amount of liquid noted on floor below pump.Infusion paused, connections checked, which were all secure.Syringe found to be leaking.We have had this problem with a particular batch of the 3ml syringes.
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Manufacturer Narrative
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B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Manufacturer Narrative
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H6: investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.H3 other text : see h10.
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Event Description
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It was reported that the bd luer-lok¿ tip disposable syringe leaked the following information was provided by the initial reporter: dose of vancomycin was scanned and placed on medfusion pump, programmed through library.During administration, liquid noted to be dripping from pump and small amount of liquid noted on floor below pump.Infusion paused, connections checked, which were all secure.Syringe found to be leaking.We have had this problem with a particular batch of the 3ml syringes.
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Search Alerts/Recalls
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