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Model Number CP3009R |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/09/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
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Event Description
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The customer reported the material of the iva seal 36 mm foil seals for the cefuroxime dose vials caps has deteriorated.The foils cannot be removed from the top of the cap in one piece, as the stripping strip remains in the hand after which it is difficult to get the final foil off the cap.There has been no problem with that foil in the past.
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Manufacturer Narrative
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There were no samples received with this complaint therefore an examination of the condition reported could not be made.From a root cause analysis perspective, the product is made to self-destruct when being removed from vials.There is a dual warning system in which seals self-destruct upon attempted removal, and needle punctures are highly visible in the laminated foil.This is to make it evident if the seal is tampered with.The slits on the seal help to ensure the product tears.Per the governing procedure for the product if upon peeling the iva seal from the container, there is evidence of the iva seal ripping, tearing, deforming or otherwise unusable.The results of the manufacturing facility investigation determined, based on the description received, the product worked as designed.No corrective or preventative actions are needed.We will continue to trend this issue for future occurrences as part of the complaint review process.
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Search Alerts/Recalls
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