MAUDE Adverse Event Report: PRODUCTOS MEDLINE MEDLINE; DBD-ODS BREAST TRAY

Catalog Number	DYNJ52685F
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The blades included in the pack displayed rust on each of them when opened.
Additional Manufacturer Narrative
It was reported that upon opening the custom pack, bd blades within the bd packages found to have rust on them.(mfg 371110 lot# 0501037).Package insert and blades passed off field and quarantined for return to company.New blades opened to complete procedure.No harm or damage to patient event did not reach patient.There were no reports of death, serious injury, medical intervention, or follow up care.

• Brand Name: MEDLINE
• Common Device Name: DBD-ODS BREAST TRAY
• Manufacturer (Section D): PRODUCTOS MEDLINE; s.a. de c.v. parque industrial; blvd world trade center #106; oradel nuevo laredo, tamaulipas 88285 ; MX 88285
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25075879
• Report Number: 1423395-2026-00126
• Device Sequence Number: 10402723
• Product Code: FTN
• UDI-Device Identifier: 10195327253004
• UDI-Public: 10195327253004
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/04/2026

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: Health Professional
• Device Catalogue Number: DYNJ52685F
• Device Lot Number: 26BBG578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown