Model Number 165812 |
Device Problems
Inadequacy of Device Shape and/or Size (1583); Material Too Soft/Flexible (4007)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/11/2022 |
Event Type
malfunction
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Event Description
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It was reported that the foley catheters were leaking and dislodging every time they inserted into the patient.This was a transgender patient converting from a female to a male.Stated that they need a stiffer or firmer foley for this patient because they need to keep the urethra open for an extended period of time because there were multiple reconstruction surgeries with this transition.Per photo sample, it was found that the foley catheter balloons were asymmetrical.The affected product catalog numbers were 165810 and 165812.
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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.
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Manufacturer Narrative
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As per review, this event is not reportable.H11:section a through f - the information provided by bd represents all of 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 the foley catheters were leaking and dislodging every time they inserted into the patient.This was a transgender patient converting from a female to a male.Stated that they need a stiffer or firmer foley for this patient because they need to keep the urethra open for an extended period of time because there were multiple reconstruction surgeries with this transition.Per photo sample, it was found that the foley catheter balloons were were lopsided which was leading to the issues that customer was expressing.The affected product catalog numbers were 165810 ( batch# ngft5821) and 165812.(batch# ngez0706 and # ngfw3722).
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Search Alerts/Recalls
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