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Model Number IPN039296 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/19/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that while in use, the belly bag is "leaking from where the inlet tube meets the bag".Additional information received states that there was no patient harm or injury, or medical intervention required.The issue was resolved by changing the bag.The patient status is reported as "fine".
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Manufacturer Narrative
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Qn#(b)(4) the sample was not returned to the manufacturer for investigation.The manufacturer reported: "since we did not receive the actual sample, we analyzed the samples with similar problems received in the past and the actual use process of the product.The position of the dome is connected with the connector, and this position is indeed susceptible to some external forces in the actual use (ie.Pulling during the assembly of the catheter, some turning and pulling during the continuous wear of it or some external force).The root cause is speculated to may be due to some external factors in the actual use process.However, without the sample the actual root cause was undetermined.A device history record review was performed, and no relevant findings were identified." teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
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Event Description
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It was reported that while in use, the belly bag is "leaking from where the inlet tube meets the bag".Additional information received states that there was no patient harm or injury, or medical intervention required.The issue was resolved by changing the bag.The patient status is reported as "fine".
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Search Alerts/Recalls
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