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Model Number FOL0100 |
Device Problems
Nonstandard Device (1420); No Apparent Adverse Event (3189)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/25/2022 |
Event Type
malfunction
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Event Description
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It was reported that the patient had used the foley statlock catheter stabilization ever since the patient started using the catheter.It was stated that in the last shipment, they noticed the design of the statlock had changed and there was not a white cover anymore.The new statlock design was just gluing the catheter into place and sometimes when the patient pulled up the pant or the registered nurse pulled up for the patient, it snugs, and it would tear.It was also stated that before the patient could snap it into place, but now it was tearing it apart.They would like to go back to the original design that they could snap it back into place.Stated that any kind of pressure that put into the statlock with the catheter, it would just tear off.The patient really liked that statlock and would like the original design.
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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.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.The device was not returned.
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Event Description
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It was reported that the patient had used the foley statlock catheter stabilization ever since the patient started using the catheter.It was stated that in the last shipment, they noticed the design of the statlock had changed and there was not a white cover anymore.The new statlock design was just gluing the catheter into place and sometimes when the patient pulled up the pant or the registered nurse pulled up for the patient, it snugs, and it would tear.It was also stated that before the patient could snap it into place, but now it was tearing it apart.They would like to go back to the original design that they could snap it back into place.Stated that any kind of pressure that put into the statlock with the catheter, it would just tear off.The patient really liked that statlock and would like the original design.
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Manufacturer Narrative
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Upon further review, bd has determined that this mdr was initially reported in error as this event is not reportable.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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