Model Number 187955 |
Device Problem
Failure To Adhere Or Bond (1031)
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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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Event Description
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It was reported by the nurse that the prod is not available to paste well near picc (venous indwelling needle) wound skin, about 3 cm place of the normal skin.There was no reported harm to the pt.
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Manufacturer Narrative
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Based on the available info, this event is deemed to be a reportable malfunction.Add'l info was requested.No add'l pt/event details have been provided to date.Should add'l info become available a f/u report will be submitted.Note: this issue occurred on (b)(6) separate pt at the same facility.A separate 3500a form has been completed for the other (b)(6) cases.
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Manufacturer Narrative
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Additional information was received on june 12, 2015.No additional patient/event details have been provided to date.Should additional information become available, a follow-up report will be submitted.
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Manufacturer Narrative
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The product associated with this complaint investigation, was made according to specification.No previous investigations are available.After detailed batch review, no discrepancies (includes non-conformances/deviations) were found.There is not enough information to conclude the product did not meet specification and perform as intended.Product monitoring reviews will monitor for product trends if this issue were to reoccur.No further actions are required, and the complaint will be closed.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).
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Search Alerts/Recalls
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