MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD PHOENIX¿ ID BROTH; CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL

Model Number	246001
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd phoenix¿ id broth missing label information.The following information was provided by the initial reporter: no label stickers.
Additional Manufacturer Narrative
H.6 investigation summary this complaint is not confirmed.This complaint is for low volumes and missing labels of phoenix id broth (246001) batch number 2167421.The customer provided photos for investigation, but no product returns.The photos illustrated a tube with the batch number present, but low fill cannot be confirmed from the photo alone.Further investigation of the retention samples of the complaint batch revealed 0/100 tubes with insufficient solution and missing labels.Based off the photos and retention samples, this complaint is not confirmed.A review of quality notifications revealed no quality notification generated on the complaint batch.A review of complaints was performed and revealed no additional complaint on the complaint batch.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.Thank you again for contacting bd and please continue to communicate any further concerns.H3 other text : see h.10.
Event or Problem Description
It was reported that bd phoenix¿ id broth missing label information.The following information was provided by the initial reporter: no label stickers.

• Brand Name: BD PHOENIX¿ ID BROTH
• Common Device Name: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL
• 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: 16075024
• Report Number: 1119779-2022-01558
• Device Sequence Number: 20391955
• Product Code: JSG
• UDI-Device Identifier: 30382902460016
• UDI-Public: 30382902460016
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 06/10/2023
• Device Model Number: 246001
• Device Catalogue Number: 246001
• Device Lot Number: 2167421
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2022
• Supplement Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 12/29/2022
• Supplement Report FDA Received Date: 01/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown