BECTON DICKINSON CARIBE LTD. BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC); SYSTEM, BLOOD CULTURING
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Model Number 442021 |
Device Problem
Contamination of Device Ingredient or Reagent (2901)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/18/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 2033624, medical device expiration date: 2022-11-30, device manufacture date: 2022-02-02, medical device lot #: 1314585, medical device expiration date: 2022-08-31, device manufacture date: 2021-11-10.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¿ lytic/10 anaerobic/f culture vials (plastic) the customer observed that multiple bactec bottles have resulted positive for sphingomonas paucimobilus.Bacteria found via subculture.This event occurred 4 total time(s) between two different lots: 2033624 and 1314585.The following information was provided by the initial reporter: "customer states multiple bactec bottles have resulted positive for sphingomonas paucimobilus.Bacteria found via subculture.".
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Event Description
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It was reported that while using bd bactec¿ lytic/10 anaerobic/f culture vials (plastic) the customer observed that multiple bactec bottles have resulted positive for sphingomonas paucimobilus.Bacteria found via subculture.This event occurred 4 total time(s) between two different lots: 2033624 and 1314585.The following information was provided by the initial reporter: "customer states multiple bactec bottles have resulted positive for sphingomonas paucimobilus.Bacteria found via subculture.".
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Manufacturer Narrative
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H.6 investigation summary catalog 442021 batch no.2033624 & 1314585 customer reported a contamination issue while using bactec product.Bd was unable to reproduce the customer¿s experience with bactec product.Retention samples were visually inspected, tested for viable contamination by sub-culturing on tsa, chocolate, sabouraud and schaedler agars plates, voltage output and gram stain.All results were satisfactory.Batch history record review did not identify any evidence for which the customer submitted the complaint.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.Satisfactory results were obtained from returned good samples (2033624) when visually inspected and tested for contamination.Complaint is unconfirmed based on retention/returned samples and batch history record review results.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.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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