Model Number 19 GAUGE |
Device Problem
Separation Failure (2547)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/15/2021 |
Event Type
malfunction
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Event Description
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Information received a smiths medical implantable ports|deltec gripper plus needles malfunctioned.Reported the joint of the needle broke off during removal, thus no function of the safety mechanism possible.No injury occurred.
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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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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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