BECTON, DICKINSON & CO. (SPARKS) BD PHOENIX¿ AST BROTH, 4.5 ML; SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
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Model Number 246011 |
Device Problem
Contamination (1120)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/12/2022 |
Event Type
malfunction
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Event Description
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It was reported by the customer that there was inconsistency volume of bd phoenix¿ ast broth, 4.5 ml and the broth changed color.There was one occurrence in this event with no patient impact.The following information was provided by the customer: " inconsistency volume of ast broth 4.5ml and the broth changed color".
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Manufacturer Narrative
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The date received by manufacturer has been used for this field.Initial reporter first name: (b)(6).Initial reporter phone number: (b)(6).Initial reporter address: (b)(6).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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Manufacturer Narrative
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Investigation summary : this complaint is confirmed.This complaint is for discolored and low volume of tubes of phoenix ast broth (246011) batch number 1239216.The customer did provide photos for investigation, but no product returns.The photos illustrated low volume of liquid within broth tubes, and discoloration.Based off the photos, this complaint is confirmed.A review of quality notifications revealed one quality notifications generated on the complaint batch.A review of complaints was performed and revealed two additional complaints on the complaint batch, related to this defect.Complaint trending was performed and no trends were identified associated with this defect.A bd id/ast plant quality will continue to monitor for trends associated with this defect.Please continue to communicate additional concerns.Per baltrmphxidastaph rev 10 version h, id 15.0, a defective product obvious to user has a severity assessment of s1.Per baltms0184 ver k a complaint with a severity ranking of s1 or s2 may require investigational testing, including retain sample analysis.However, the customer returned photos which were used for the investigation; therefore, a review of retention samples is not required.
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Event Description
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It was reported by the customer that there was inconsistency volume of bd phoenix¿ ast broth, 4.5 ml and the broth changed color.There was one occurrence in this event with no patient impact.The following information was provided by the customer: " inconsistency volume of ast broth 4.5ml and the broth changed color".
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