Model Number IPN917235 |
Device Problem
Crack (1135)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/16/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Qn#(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
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Event Description
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The report states that "we used 2 different berman 5 x 80 catheters today and both times the hub cracked during an injection.We were within the limits of psi and flow rates listed on the package.They were both from the same lot." additional information states "the catheters were used on the same patient.Physician was able to see enough of the lv with the partial injection.No medical intervention was required.Pt went home as planned." see associated mdr 3010532612-2023-00045.
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Manufacturer Narrative
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(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
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Event Description
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The report states that "we used 2 different berman 5 x 80 catheters today and both times the hub cracked during an injection.We were within the limits of psi and flow rates listed on the package.They were both from the same lot." additional information states "the catheters were used on the same patient.Physician was able to see enough of the lv with the partial injection.No medical intervention was required.Pt went home as planned." see associated mdr 3010532612-2023-00045.
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Search Alerts/Recalls
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