Model Number 714120 |
Device Problems
Fluid/Blood Leak (1250); Unintended Deflation (4061)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/23/2022 |
Event Type
malfunction
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Manufacturer Narrative
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An investigation is currently underway.Upon completion, the results will be forwarded.
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Event Description
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As reported by the customer: the device had to be replaced due to a leak in the balloon which was possibly due to a rupture.Additional information provided on 2/25/22 stated that after 15 days of use, a leak was found inside the patient and the device was removed and replaced with a new device.The patient experienced no complications and is in good condition.On 2/28/22 further information was provided stating that the client uses sterile water to inflate the cuff, as soon as the balloon ceased to be tight, the customer noticed that the tube could slip out and the administered nutritional formula was leaking.
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Manufacturer Narrative
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An investigation is currently underway.Upon completion, the results will be forwarded.
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Event Description
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As reported by the customer: the device had to be replaced due to a leak in the balloon which was possibly due to a rupture.Additional information provided on 2/25/2022 stated that after 15 days of use, a leak was found inside the patient and the device was removed and replaced with a new device.The patient experienced no complications and is in good condition.On 2/28/2022 further information was provided stating that the client uses sterile water to inflate the cuff, as soon as the balloon ceased to be tight, the customer noticed that the tube could slip out and the administered nutritional formula was leaking.
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Manufacturer Narrative
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The device history record review of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation.One decontaminated nutriport balloon 14fr x 1.2cm.Without the original packaging identified as lot 2109720164 was received for evaluation.A visual inspection according to procedure, and a functional test was performed according to product specification concluded that when the balloon was filled with sterilized water, a leak was observed under the balloon.The root cause and action plan will be documented through a formal corrective/preventative action (capa) which has been initiated to address the reported condition to mitigate any further occurrences.This action is currently ongoing.This complaint will be closed with no further action and will be used for tracking and trending purposes.
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Search Alerts/Recalls
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