MAUDE Adverse Event Report: Productos Medline S.A. de C.V. Medline; STERILE BLOOD CULTURE

Catalog Number	DYNDH1348C
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2026
Type of Reportable Event	Malfunction

• Brand Name: Medline
• Common Device Name: STERILE BLOOD CULTURE
• Manufacturer (Section D): Productos Medline S.A. de C.V.; blvd world trade center 106; parque industrial oradel; nuevo laredo, tamaulipas 88285 ; MX 88285
• Manufacturer Contact: nithla mathivanan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50509809
• Report Number: 3004122598-2026-00079
• Device Sequence Number: 18631244
• Product Code: OIB
• UDI-Device Identifier: 10195327315559
• UDI-Public: 10195327315559
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: N/a
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/28/2026

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
• Device Catalogue Number: DYNDH1348C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 08/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown