Model Number N/A |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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The information provided by bard 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 bard.The device has not been returned to the manufacturer for evaluation, as the device remains in the patient.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
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Event Description
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On (b)(6) 2017 - the patients mother reported that the button that was placed in (b)(6) of 2016, had been leaking for approximately one week.She stated that the valve was beginning to fail.During feedings the valve leaked where the feeding tube plugs into the button.When the feeding tube was removed the button did not leak; the valve was holding.If the button begins to leak after the feeding tube is removed, the device will be replaced and returned for evaluation.
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Manufacturer Narrative
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The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a leak through the valve of the button device was confirmed, but the exact cause was unknown.Two 24fr x 2.4 cm button replacement devices were returned for investigation.Sample #1 was labeled as the ¿bad¿ button device.Sample #2 was labeled as a ¿good¿ button device.An attempt to siphon water through the button devices revealed that fluid could only be drawn through sample #1.After removing the dome, a gap was visible between the valve and the bottom of the button shaft, which may have been a contributing factor in the reported event, but the exact cause of the gap or the leak was unknown.Particles of feeding material was observed in the valve hinge.No fluid leaked from the button replacement device when the strap was closed.The product ifu indicates to close the safety plug to keep the lumen clean and to minimize reflux.
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Event Description
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2/13/2017 - the patient's mother reported that the button that was placed in (b)(6) 2016, and had been leaking for approximately one week.She stated that the valve was beginning to fail.During feedings the valve leaked where the feeding tube plugs into the button.When the feeding tube was removed the button did not leak; the valve was holding.If the button begins to leak after the feeding tube is removed, the device will be replaced and returned for evaluation.
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Search Alerts/Recalls
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