Model Number 10012143 |
Device Problems
Fluid/Blood Leak (1250); Fracture (1260)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.
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Event Description
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The customer reported a leak while the product was attached to a patient.There was no report of patient harm.
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Event Description
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The customer reported a leak while the product was attached to a patient.There was no report of patient harm.The product was then received with a note stating, "crack where syringe connected to tubing".
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Manufacturer Narrative
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Concomitant medical products: 10ml bd syringe, ref (b)(4), lot number 8018972, exp 2020-12-31, 0.9% sodium chloride.The device has been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.
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Manufacturer Narrative
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The customer¿s report of leaking was confirmed.During visual inspection a residual red/brown substance resembling blood was observed in the set.A vertical crack around 14mm in length was visible on the female luer, extending from the luer opening and down into the luer body.A vertical micro-fracture leading into the larger vertical crack was also observed on the luer body.Functional testing showed a leak at the connection of the syringe to female luer of the set.The root cause of the customer's report was a result of multiple contributing factors such as material regrind, gate location and the effect of chemical agents on mechanical connections of the luer.
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Event Description
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The customer reported a leak while the product was attached to a patient.There was no report of patient harm.The product was then received with a note stating, "crack where syringe connected to tubing".
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Search Alerts/Recalls
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