BECTON, DICKINSON & CO. (SPARKS) BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC); SYSTEM, BLOOD CULTURING
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Model Number 442020 |
Device Problem
False Positive Result (1227)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/06/2022 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.Medical device expiration date: unknown.Device manufacture date: unknown.
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Event Description
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It was reported that while using bd bactec¿ peds plus¿/ f culture vials (plastic) the customer was complaining for false positive pediatric vial, lot no.1294782, this bottle also false positive for proteus in blood culture bottles.The following information was reported "the customer indicates, no gram stain prior to make molecular test, no observable defect on the bottles, or extreme ambient conditions prior to use.These vials were purchased directly to bd, quantity pending to confirmation.
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Manufacturer Narrative
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H.6.Investigation summary catalog 442020; batch no.1294782.Customer reported false positive result.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 could not be reviewed as the lot is expired, nonetheless batch history records are always reviewed prior to product release.Users are cautioned in the package insert under limitation of the procedure: ¿a gram-stained smear from culture medium may contain small number of non-viable organisms derived from media constituents, staining reagents, immersion oil, glass slide and specimens used for inoculation.There are many factors that can influence the false positive rate, including blood volume, blood cell counts, environmental factors, and media lot to lot variations.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.H3 other text : see h.10.
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Event Description
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It was reported that while using bd bactec¿ peds plus¿/ f culture vials (plastic) the customer was complaining for false positive pediatric vial, lot no.1294782, this bottle also false positive for proteus in blood culture bottles.The following information was reported "the customer indicates, no gram stain prior to make molecular test, no observable defect on the bottles, or extreme ambient conditions prior to use.These vials were purchased directly to bd, quantity pending to confirmation.
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Search Alerts/Recalls
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