Catalog Number 61979010 |
Device Problems
Device Damaged Prior to Use (2284); Manufacturing, Packaging or Shipping Problem (2975); Moisture or Humidity Problem (2986)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Information (3190)
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Event Date 11/17/2015 |
Event Type
malfunction
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Manufacturer Narrative
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An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.
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Event Description
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It was reported, "hospital contacted us to report they received one case of cement wet.They did not notice a smell coming from the box so they could not tell if it was water damaged or if a vial had broken.They said the case was unsalvageable and would be disposed of as hazardous waste.Cement was delivered via (b)(6) and the damage was reported to (b)(6) by the hospital.".
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Manufacturer Narrative
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An event regarding packaging damage involving simplex with tobramycin bone cement was reported.The event was not confirmed.Method and results: device evaluation and results: not performed as no devices were returned and no photographs were provided.Medical records received and evaluation: not performed as there was no patient involvement.Device history review: review of the batch manufacturing record indicates that this batch was manufactured and shipped to stock with no reported discrepancies.Complaint history review: review determined that there were no other similar reported events for the lot.Conclusions: the event was not confirmed as no devices or photographs were provided for review.Based on the information provided by the customer, the box was wet.This indicates that an ampoule was broken at the time or shortly before the product was received by the customer as the box was wet.The liquid from the ampoule lasts a short period of time as the liquid evaporates when exposed to the atmosphere.Based on the information provided, it appears that this product was damaged due to inappropriate handling during distribution/transportation.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
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Event Description
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It was reported, "hospital contacted us to report they received one case of cement wet.They did not notice a smell coming from the box so they could not tell if it was water damaged or if a vile had broken.They said the case was unsalvageable and would be disposed of as hazardous waste.Cement was delivered via (b)(6) and the damage was reported to (b)(6) by the hospital.".
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Search Alerts/Recalls
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