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Catalog Number 21-2768-24 |
Device Problems
Detachment of Device or Device Component (2907); Fail-Safe Did Not Operate (4046)
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Patient Problems
No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/01/2020 |
Event Type
malfunction
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Event Description
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Information was received indicating that the safety mechanism was triggered when the deltec gripper plus needle was removed.When placing the needle on a surface, it suddenly jumps apart, the safety mechanism detaches, and the needle is then exposed.There were no adverse events reported.
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Manufacturer Narrative
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No product information has been provided to date.This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A product sample was received for evaluation.Visual and functional testing were performed.No problems or issues were identified during this device history record review.Six (6) pictures attached for evaluation: observe safety mechanism detached, broken.The sample consist of one (1); the returned sample was received decontaminated without its original packaging.Functional test: activated the safety mechanism to see if there was any issue.Observe safety mechanism was broken, the failure mode reported was confirmed.The most probable root cause is that the product became damaged after it left manufacturing facility.All mitigations on placed were verified and it was confirmed has been executing according, therefore no corrective actions could be implemented, it will be continue monitoring this failure condition in this product for threshold or escalation.Production personnel was notified by quality engineer on 25/feb/2021 as awareness of the defect reported by the customer.
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Search Alerts/Recalls
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