Catalog Number 778400 |
Device Problem
Incorrect Measurement (1383)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/05/2024 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Event Description
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It was reported that customer had a defective stent during surgery.The pusher (orange) was larger in lumen size and the stent, so it was sliding over the stent not pushing it up.
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Manufacturer Narrative
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The reported event is unconfirmed as the product meets specifications.No root cause could be found because the reported event was unconfirmed.Dhr review is not required as the reported event is unconfirmed.Labelling review is not required as the reported event is unconfirmed.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the actual/suspected device was inspected.
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Event Description
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It was reported that customer had a defective stent during surgery.The pusher (orange) was larger in lumen size and the stent, so it was sliding over the stent not pushing it up.Per additional information received via sample form on 06feb2024, during the procedure the surgeon was advancing the stent up the ureter to the position using the pusher (orange piece).The pusher slid over the end of the stent caused it to become stuck.The surgeon removed both the stent and the pusher and placed a new stent.The lumen of the pusher (orange) was larger than the diameter of the stent caused it to slide over the stent instead of pushed it up.No patient impact due to the use of the device.No medical intervention required.Device was replaced with a new stent.
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Search Alerts/Recalls
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