Catalog Number 170003-000080 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/04/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
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Event Description
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It was reported that the pediatric department reported incidents with this reference (b)(4).With sizes 80 and 100, lot# 19fe25.The catheter separated from the "y" connector.The clinical consequences are unknown at the time of logging.Additional information: there was the usual tension of a child who tries to remove his urinary catheters by himself.But we did not have such a break with other suppliers.
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Event Description
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It was reported that the pediatric department reported incidents with this reference (b)(4).With sizes 80 and 100, lot# 19fe25.The catheter separated from the "y" connector (see picture).The clinical consequences are unknown at the time of logging.Additional information: there was the usual tension of a child who tries to remove his urinary catheters by himself.But we did not have such a break with other suppliers.
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Manufacturer Narrative
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Qn# (b)(4).The batch card(s) for the complaint lot(s) was reviewed and passed qa inspection.Based on the complaint description and from the image provided, it was a catheter broke between the funnel joint and the catheter shaft.However, there was no actual sample returned for evaluation and further investigation could not be conducted.It is difficult to identify the actual root cause of this reported failure.Therefore, this complaint could not be confirmed.
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Search Alerts/Recalls
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