BECTON, DICKINSON & CO. (SPARKS) BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC); SYSTEM, BLOOD CULTURING
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Model Number 442023 |
Device Problem
False Negative Result (1225)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/01/2022 |
Event Type
malfunction
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Event Description
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It was reported that while using bd bactec¿ plus aerobic/f culture vials (plastic) there was one false negative blood culture.The aerobic bottle was detected as negative in the bactec fx, but the gram preparation and the subculture were positive with e.Coli and enterococcus faecalis.Results were not reported to the clinician and there was no patient impact.The following information was provided by the initial reporter: 02-sep-2022 - additional info: material: punctate of an abscess of the lumbar spine the false negative result has not been submitted to the hospital, so no impact for the patient.False negative blood culture.Renewed complaint about a false negative blood culture bottle.The aerobic bottle is detected as negative in the bactec fx, the gram preparation and the subculture are positive with e.Coli and enterococcus faecalis.The anaerobic bottle is positive in the device, also with e.Coli and enterococcus faecalis.The sample material in both bottles was a punctate.Growth curves and the vial picture are attached.Log files will be submitted later by the customer.Is a negative bottle from the instrument always gram stained and subcultured?---> no if not, why did they do it in this case? the patient sample is an abscess puncture of the lumbar spine.One aerobic and one anaerobic bactec vial was inoculated.Patient sample was not clear/turbid so it was gram stained and subcultures were made.Gram stain: gram positive cocci and gram negative rods.Subculture: e.Faecalis (pos.Cocci) , no growth of gram negative rods so far.
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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.
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Event Description
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It was reported that while using bd bactec¿ plus aerobic/f culture vials (plastic) there was one false negative blood culture.The aerobic bottle was detected as negative in the bactec fx, but the gram preparation and the subculture were positive with e.Coli and enterococcus faecalis.Results were not reported to the clinician and there was no patient impact.The following information was provided by the initial reporter: 02-sep-2022 - additional info: material: punctate of an abscess of the lumbar spine the false negative result has not been submitted to the hospital, so no impact for the patient.False negative blood culture.Renewed complaint about a false negative blood culture bottle.The aerobic bottle is detected as negative in the bactec fx, the gram preparation and the subculture are positive with e.Coli and enterococcus faecalis.The anaerobic bottle is positive in the device, also with e.Coli and enterococcus faecalis.The sample material in both bottles was a punctate.Growth curves and the vial picture are attached.Log files will be submitted later by the customer.Is a negative bottle from the instrument always gram stained and subcultured?---> no.If not, why did they do it in this case? ---> the patient sample is an abscess puncture of the lumbar spine.One aerobic and one anaerobic bactec vial was inoculated.Patient sample was not clear/turbid so it was gram stained and subcultures were made.Gram stain: gram positive cocci and gram negative rods.Subculture: e.Faecalis (pos.Cocci) , no growth of gram negative rods so far.
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Manufacturer Narrative
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H.6 investigation summary: one photo of a bottle was 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.Product insert warnings and precautions sections states that prior to use, each vial should be examined for evidence of contamination such as cloudiness, bulging or depresses septum, or leakage.Vials showing evidence of contamination should not be used.Also prior to use, the user should examine the vial for evidence of damage or deterioration.Vials displaying turbidity, contamination, or discoloration (darkening) should not be used.The specimen must be collected using sterile techniques to reduce the chance of contamination.Do not use culture vials past their expiration date.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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