Model Number 995081 |
Device Problem
Nonstandard Device (1420)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/25/2023 |
Event Type
malfunction
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Event Description
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It was reported that in an online survey a physician stated no to the question when they were asked if they were able to use the refolding tool to refold the balloon dilation catheter for reinsertion.The physician was not able to use the refolding tool to refold the 995081 - x-force® nephrostomy balloon dilation catheter, 8mm x 15cm, sterile because physician stated they were not sure.
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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.H3 other text : the device was not returned.
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Event Description
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It was reported that in an online survey a physician stated no to the question when they were asked if they were able to use the refolding tool to refold the balloon dilation catheter for reinsertion.The physician was not able to use the refolding tool to refold the 995081 - x-force® nephrostomy balloon dilation catheter, 8mm x 15cm, sterile because physician stated they were not sure.
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Manufacturer Narrative
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The reported event is inconclusive as no sample was returned for evaluation.Although an exact root cause could not be determined a potential root cause could be improper material selection.The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿description: the balloon dilation catheter comes packaged with a refolding tool and a working sheath.It is available with or without an inflation device.It comes sterile and is for single use only.Using the refolding tool: the balloon catheter is supplied with a refolding tool.This aids in preparing the balloon for another insertion during the procedure.To use: manually compress the balloon.Position the refolding tool at one end of the balloon.Twist the refolding tool counterclockwise and push down on the balloon until the refolding tool traverses the entire length of the balloon.4.Once the balloon is folded, remove the refolding tool and proceed with the procedure.Dispose of properly.¿ 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 device was not returned.
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Search Alerts/Recalls
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