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Catalog Number D5LT |
Device Problem
Fracture (1260)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/02/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Per photographic evaluation: there was no sample received for analysis.Only pictures of the sample was received for analysis.Upon visual inspection of the pictures, a damage was noted to be on the sleeve of the device.However, no conclusion could be reached as to the origin of the damage as the device was not returned for analysis.The photos do not provide enough evidence to determine root cause.Hands on analysis should provide the evidence necessary to confirm the root cause.The lot history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.
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Event Description
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It was reported the device was requested to the pharmacy, in the service of surgery.It was detected, when removing it from the package, that the tip of the device was fractured.
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Search Alerts/Recalls
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