Catalog Number 8310.27G12 |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/15/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The complaint is under investigation.
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Event Description
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We were informed that the tyvek lid on the blister is not properly sealed.The product has not been used.No patient harm occured.
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Manufacturer Narrative
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In regard to this event, the product was recently returned for investigation.Please note that the investigation to determine the root cause of the reported event is ongoing.
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Event Description
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We were informed that the tyvek lid on the blister is not properly sealed.The product has not been used.No patient harm occured.
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Manufacturer Narrative
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Though the complaint form indicated that the tyvek lids on the blisters were not sealed properly, a subsequent email from customer service stated that "the packs were not unsealed, but broken".In regard to this complaint, two 27 gauge eva tdc vitrectomy packs were returned for investigation.Visual inspection of the returned product confirmed the presence of cracks in the blisters.Since all blister packs are visually inspected prior to being released for distribution, the observed damage must have occurred after the product left the controls of dorc.The observed cracks suggest transport damage; however, since no information was received on the state of the secondary packaging, improper handling of the blisters after they were removed from the cardboard box cannot be ruled out.The risk identified is included in the risk management documentation.Trend analysis indicates that the product is performing within anticipated rates.Therefore, no remedial or corrective/preventive actions will be undertaken at this moment.Complaints will be closely monitored to identify any significant adverse trends.
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Event Description
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We were informed that the tyvek lid on the blister is not properly sealed.The product has not been used.No patient harm occured.
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Search Alerts/Recalls
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