Model Number B1100-020 |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/09/2023 |
Event Type
malfunction
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Event Description
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It was reported that the shipping box was cut open and the product was taken out of the shipping box, when it was noticed that the chipboard box was cut open as well.The sterile packaging was possibly damaged; therefore, sterility is unknown.The device was not used in a patient.There was no patient involvement and no clinically significant delays in the procedure.No additional information was provided.
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Manufacturer Narrative
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Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
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Manufacturer Narrative
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The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot.The investigation was unable to determine a conclusive cause for the reported complaint.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.D9 - device available for evaluation updated from ¿yes¿ to ¿no¿.
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Search Alerts/Recalls
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