MAUDE Adverse Event Report: LEE LABORATORIES, INC. BD DIFCO¿ SALMONELLA H ANTISERUM SINGLE FACTOR T; ANTISERA, ALL GROUPS, SALMONELLA SPP.

Catalog Number	225511
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Initial reporter addr 1:(b)(6).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 prior to use of bd difco¿ salmonella h antiserum single factor t, the label was missing on one vial.There was no health impact or consequences reported.
Event or Problem Description
It was reported prior to use of bd difco¿ salmonella h antiserum single factor t, the label was missing on one vial.There was no health impact or consequences reported.
Additional Manufacturer Narrative
Investigation summary: to investigate the complaint received on salmonella h antiserum t, catalog 225511, lot 2349770 the complaint entry description was reviewed.After reading through the entry description, it was determined that the customer is complaining on receiving one vial of salmonella h antiserum unlabeled.A return sample was not received, as a substitute the customer provided photographic evidence.A photo analysis was performed, the photo shows the secondary carton of the complaint lot beside the unlabeled vial.Based on the photo analysis performed the complaint is confirmed.The batch history record for the complaint lot was reviewed and found satisfactory; no discrepancies were noted during the labeling process.Retained samples of the complaint lot was inspected and labels were found to be compliant.Complaints for the product line were reviewed covering a three-year period.There have been no other complaints received on the catalog or lot number in the period reviewed.Lot 2349770 was released on september 17, 2022, the lot size was approximately one hundred and twenty-seven vials.To date no other complaints have been received related to unlabeled vials.This appears to be an isolated incident; bd will continue to monitor for trends related to label discrepancies.

• Brand Name: BD DIFCO¿ SALMONELLA H ANTISERUM SINGLE FACTOR T
• 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: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 20759506
• Report Number: 1025402-2024-00010
• Device Sequence Number: 9291949
• Product Code: GRM
• UDI-Device Identifier: 00382902255116
• UDI-Public: (01)00382902255116(11)221215(17)260501(10)2349770
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2024

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: 05/01/2026
• Device Catalogue Number: 225511
• Device Lot Number: 2349770
• 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: 10/29/2024
• Supplement Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2022
• 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