MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD PHOENIX¿ AST BROTH; SEE H.10

Model Number 246003

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/05/2022

Event Type  malfunction  

Manufacturer Narrative

Common device name: system, test, automated antimicrobial susceptibility, short incubation.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that while using the bd phoenix¿ ast broth that there was a labeling issue.The following information was provided by the initial reporter: this is a report about a labeling issue.According to the customer¿s report, there was a broth tube with 2 labels (one overlapping the other), and a tube without a label.

Manufacturer Narrative

H.6 investigation summary: this complaint is confirmed.This complaint is for missing and misplaced labels on tubes of phoenix ast broth (246003) batch number 2146686.The photos showed two tubes, one without a label and one with two labels and the batch number present.The returns show the missing and displaced label on two tubes.Based off the photos and return samples, this complaint is confirmed.A review of quality notifications revealed no quality notification generated on the complaint batch.A review of complaints was performed and revealed one additional complaint on the complaint batch, not 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.The following are guidelines to help minimize phoenix ast issues: media selection: isolates must be recovered from non-selective media.See table 16 recommended media in the bd user manual for a list of recommended media.Ensure quality of vendor selection for plated media.Variations in formulations may impact results.Culture handling: cultures must be 18-24 hours old for gram-negative & gram-positive organisms and 18-48 hours old for yeast organisms.For qc organisms, ensure organisms have been subcultured at least twice on two consecutive days on proper nonselective media (gram-negative or gram-positive organisms: tsa with 5% sheep blood, yeast: sabouraud dextrose agar).Mcfarland preparation: use of a low-quality sterile cotton swab, which shed fibers, could potentially contribute to a falsely high mcfarland reading.Polyester swabs are not recommended.Ensure bd approved nephelometer is adequately calibrated with not expired mcfarland calibration tubes.Prepared tubes should be vortexed for 5 seconds and allowed approximately 10 seconds for air bubbles to surface.Ensure mcfarland falls within proper range of the inoculum density.For 0.5 mcfarland system, 0.50-0.60 is acceptable.For 0.25 mcfarland system, 0.20-0.30 is acceptable.For yeast panels, 2.00-2.40 is acceptable.Confirm current instrument settings for inoculum density before inoculating panels.For example, ensure a 0.50 mcfarland was not prepared for a 0.25 inoculum density instrument setting.Use bacterial suspensions within 60 minutes of preparation.Panel preparation: panels should be used within 2 hours of removal from pouch.Inoculate panels within 30 minutes of the time that the ast broth inoculum is prepared.Allow sufficient time for fluid to traverse down the well tracks before moving the panel.Avoid touching the front and backside of the panel.Handle panels by the sides to avoid producing smudges on the surface of the panels.Inoculated panels should be handled with care.Avoid knocking or jarring the panel.Load panels into instrument within 30 minutes of inoculation.

Event Description

It was reported that while using the bd phoenix¿ ast broth that there was a labeling issue.The following information was provided by the initial reporter: this is a report about a labeling issue.According to the customer¿s report, there was a broth tube with 2 labels (one overlapping the other), and a tube without a label.

• Brand Name: BD PHOENIX¿ AST BROTH
• Type of Device: SEE H.10
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16030216
• MDR Text Key: 306839771
• Report Number: 1119779-2022-01495
• Device Sequence Number: 1
• Product Code: LON
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K020321
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/19/2023
• Device Model Number: 246003
• Device Catalogue Number: 246003
• Device Lot Number: 2146686
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1