MAUDE Adverse Event Report: LEE LABORATORIES, INC. BD DIFCO¿ SALMONELLA O ANTISERUM GROUP E FACTORS 1, 3, 10, 15, 19, 34; ANTISERA, ALL GROUPS, SALMONELLA SPP.

Catalog Number	228191
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd difco¿ salmonella o antiserum group e factors 1, 3, 10, 15, 19, 34, there was a performance issue of one vial.The performance issue is unable to be listed as insufficient information was provided.No patient impact reported.The following information was provided by the initial reporter: "can't be tested".
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted report 1025402-2023-00044 was sent in error.There was no report of serious injury, medical intervention, or reportable device malfunction.Therefore, this is not considered to be a reportable malfunction.
Event or Problem Description
It was reported that while using bd difco¿ salmonella o antiserum group e factors 1, 3, 10, 15, 19, 34, there was a performance issue of one vial.The performance issue is unable to be listed as insufficient information was provided.No patient impact reported.The following information was provided by the initial reporter: "can't be tested.".

• Brand Name: BD DIFCO¿ SALMONELLA O ANTISERUM GROUP E FACTORS 1, 3, 10, 15, 19, 34
• Common Device Name: ANTISERA, ALL GROUPS, SALMONELLA SPP.
• Manufacturer (Section D): LEE LABORATORIES, INC.; 1475 athens highway; grayson GA 30017
• Manufacturer (Section G): LEE LABORATORIES, INC.; 1475 athens highway; grayson GA 30017
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17953655
• Report Number: 1025402-2023-00044
• Device Sequence Number: 6715419
• Product Code: GRM
• UDI-Device Identifier: 00382902281917
• UDI-Public: 00382902281917
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2023

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 Expiration Date: 04/13/2026
• Device Catalogue Number: 228191
• Device Lot Number: 3089158
• 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: 09/18/2023
• Supplement Date Received by Manufacturer: 09/18/2023
• Initial Report FDA Received Date: 10/17/2023
• Supplement Report FDA Received Date: 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2023
• 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