Catalog Number CLR222US |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/01/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
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Event Description
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It was reported during inventory inspection that it was found that the package had a crack on the corner and there was a concern for the sterility of the product.The sample will be returned for evaluation.
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Manufacturer Narrative
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Product complaint # (b)(4).Date sent to fda: 12/7/2018.
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Manufacturer Narrative
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Product complaint # (b)(4).Date sent to fda: 12/29/2018.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.Additional evaluation summary: the sample was returned for evaluation.The analysis results found that the device was returned inside its package unopened.Upon visual inspection of the device, it was observed that the blister tray of the returned unit was broken in one of the corners.The pen device was observed to be without damages.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Due to the damages found on the packaging, a possible cause for these conditions is due to improper handling during transit or storage.
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Search Alerts/Recalls
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