Catalog Number 326716 |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/25/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that syringe 1ml 27ga 1/2in p cust had stains and foreign matter.Out of 800 pieces an unspecified number were involved.The following information was provided by the initial reporter: brown stains on the blister.Foreign particles inside the blister.Black stains on the plastic of the syringe cap.Black stains on the blister.
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Event Description
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It was reported that syringe 1ml 27ga 1/2in p cust had stains and foreign matter.Out of 800 pieces an unspecified number were involved.The following information was provided by the initial reporter: brown stains on the blister.Foreign particles inside the blister.Black stains on the plastic of the syringe cap.Black stains on the blister.
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Manufacturer Narrative
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H6: investigation summary: a physical sample from the customer was received in which it is possible to observe a brown stain in the upper syringe sealing the customer defect reported is confirmed.It is important to mention that this brown stain could be generated due to water condensation of air to into contact with the heat-sealing plates.Review of the batch 0226071 no quality events records in the product manufacture were found, the batch was inspected and later released accordance with the valid work instruction h3 other text : see h10.
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Search Alerts/Recalls
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