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Model Number 72205292 |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/15/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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Event Description
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It was reported that an unusual packaging was noticed for a platinum flyer blade.Upon further inspection it was realized that sterile seal was compromised.No case reported; therefore, there was no patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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H10: h3, h6: the reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.Two devices from lot number 50903212 were returned for evaluation.A visual inspection found the sterile barrier on both devices were breached and the inner side of tyvek packaging had blue print.The thermoformed number on the clear plastic tray of the first device was a 2, however the second devices was a 4.Analysis of the customer provided images confirmed blue print on the inner side of the tyvek packaging.The sterile barrier was compromised.The thermoformed number on the clear plastic tray of the first device was a 2, however the second devices was a 4.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was a repeat issue.A review of the visual inspection and seal machinery process summaries confirmed the device is inspected for comprised seal integrity and abnormalities.The complaint was confirmed and the root cause was associated with manufacturing.A complaint notification has been issued to manufacturing management to mitigate future recurrences.
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Search Alerts/Recalls
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