Catalog Number 442020 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/18/2024 |
Event Type
malfunction
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Manufacturer Narrative
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H3.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 while using bd bactec¿ peds plus¿/ f culture vials (plastic) contamination was found.No patient impact reported.
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Event Description
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It was reported that while using bd bactec¿ peds plus¿/ f culture vials (plastic) contamination was found.No patient impact reported.
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Manufacturer Narrative
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H.6 investigation summary: catalog 442020.Batch no.3137615.Customer reported a contamination issue.Neither photos nor returned good samples were received.Upon further evaluation it was noticed that complaint received was from a product already expired.Investigation cannot be conducted to the retention samples since the product is already expired.A complaint history review was conducted and only the current complaint was found relating to the incident lot number and the ¿as reported¿ defect code.The batch history record was not reviewed as the lot is expired, nonetheless batch history records are always reviewed prior to product release.Complaint is unconfirmed.No corrective actions were required.A cross functional team continually monitors all product complaints for trends and determines if any additional actions are necessary beyond the current investigational process.
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Search Alerts/Recalls
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