Catalog Number 21-2768-24 |
Device Problem
Fail-Safe Problem (2936)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/07/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Customer contact phone number: (b)(6).
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Event Description
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It was reported that the deltec gripper plus was removed from use with patient and the user attempted to withdraw the metal needle into the safety mechanism.The reporter stated that the device broke apart and the safety arm was detached from the rest of the device.No adverse effects to patient or user were reported.
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Manufacturer Narrative
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Other, other text: twelve pictures were attached and it could be seen that the safety mechanism was broken and the needle was out of it.The complaint is confirmed.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.
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Search Alerts/Recalls
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