Model Number 2D7255I |
Device Problems
Entrapment of Device (1212); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 05/01/2019 |
Event Type
malfunction
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Manufacturer Narrative
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At the time of this investigation no sample or lot number was provided.Without the lot number and sample, we were not able to review the device history record (dhr) and we were not able to evaluate the issue sample.We were unable to determine the root cause for the reported event.If a sample is provided at a later date a follow-up will be provided.At this time no corrective action will be taken.We will continue monitoring our customer complaints data base for this and any other issues reported of the same nature.
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Event Description
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Based on information received from the customer, a chest tube was inserted on (b)(6) 2019 and then replaced on (b)(6) 2019 when the patient later had surgery a fingertip of the glove was reportedly found in the chest cavity.The physician was unaware it had pulled off.
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Search Alerts/Recalls
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