Catalog Number L5C4531 |
Device Problems
Hole In Material (1293); Melted (1385)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that a homechoicecassette was "melted in the over pouch with a hole in the patient line." the caregiver had discovered the issues prior to therapy and the supplies were not used.The caregiver had not used any sharp objects to open the packages, and there was no mention of damage to the shipping cartons.The registered nurse stated the supplies had been stored in a room temperature environment.There was patient involvement.There was no patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not returned; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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