BECTON DICKINSON CARIBE LTD. BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC); SYSTEM, BLOOD CULTURING
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Model Number 442023 |
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 11/19/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported while testing with bd bactec¿ plus aerobic/f culture vials (plastic), a false positive result was obtained.Confirmatory gram testing was performed and the result was negative.The false positive result was not reported, and there was no patient impact.The following information was provided by the initial reporter: the vial is flagged positive 55 min after insertion.The customer is reporting that it is defective vial.
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Event Description
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It was reported while testing with bd bactec¿ plus aerobic/f culture vials (plastic), a false positive result was obtained.Confirmatory gram testing was performed and the result was negative.The false positive result was not reported, and there was no patient impact.The following information was provided by the initial reporter: the vial is flagged positive 55 min after insertion.The customer is reporting that it is defective vial.
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Manufacturer Narrative
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H.6.Investigation: customer reported blood under the sensor and false positive result.Three photos with sensor adhesion defect were received.Bd was unable to duplicate customer¿s experience with the bactec product.Retention samples were visually inspected with satisfactory results.Batch/sensor history records were reviewed, and all testing were within specification for product release.Blood background was performed with satisfactory results.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.Sensor adhesion scrape test is performed to each sensor batch as part of release criteria.Complaint is confirmed based on photos received.The vision system is challenged prior each lot.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.Capa#2882676 was initiated to further investigate these types of complaints and determine any appropriate actions to reduce their occurrence.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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Search Alerts/Recalls
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