MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD PHOENIX¿ PMIC-107; SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

Catalog Number	448417
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd phoenix¿ pmic-107 that there was incorrect label information.The following information was provided by the initial reporter: correction: when reviewing documentation on the bd website the ifu for cat # 448417 incorrectly loads the ifu for cat # 448608, technical services identified a discrepancy in the ifu record.No impact to patients or customers was associated with this discrepancy at this time.
Additional Manufacturer Narrative
D4.Medical device lot #: unknown.D4.Medical device expiration date: unknown.H4.Device manufacture date: unknown.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that while using bd phoenix¿ pmic-107 that there was incorrect label information.The following information was provided by the initial reporter: correction: when reviewing documentation on the bd website the ifu for cat # 448417 incorrectly loads the ifu for cat # 448608, technical services identified a discrepancy in the ifu record.No impact to patients or customers was associated with this discrepancy at this time.
Additional Manufacturer Narrative
H.6.Investigation summary: this complaint is confirmed.This complaint is for a discrepancy in the electronic instructions for use (eifu) when using phoenix panel pmic-107 (448417) batch number unknown.The customer did not provide product returns but provided photos for the investigation.The photos show the panel information for pmic-107, and the eifu for pmic/id-108.The bd labeling team has reviewed the issue and confirmed an incorrect document was displayed on the eifu site.A technical issue with the document link was identified as part of this complaint and a corrective and preventative action was initiated in order to ensure the issue is being addressed and corrected moving forward.The bd eifu site also directs users to customer service in the event an error is in place with the site.A copy of the ifu can be requested by contacting bd technical services.A review of quality notifications could not be performed since a batch number was not provided.A review of complaints could not be performed since a batch number was not provided.Complaint trending was performed and no trends were identified associated with this defect.Bd id/ast plant quality will continue to monitor for trends and take action as necessary.H3 other text : see h.10.

• Brand Name: BD PHOENIX¿ PMIC-107
• Common Device Name: SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17633653
• Report Number: 1119779-2023-00950
• Device Sequence Number: 7618203
• Product Code: LON
• UDI-Device Identifier: 30382904484171
• UDI-Public: 30382904484171
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K031679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2023

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 Catalogue Number: 448417
• Device Lot Number: UNKNOWN
• 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: 08/21/2023
• Supplement Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 08/28/2023
• Supplement Report FDA Received Date: 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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