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 by the rep during inventory inspection it was found that the packages all had cracks on the corner of the packaging and there was a concern for the sterility of the product.Samples will be returned.
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Manufacturer Narrative
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Product complaint # (b)(4).A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.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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