MAUDE Adverse Event Report: CARDINAL HEALTH PREFILLED FORMALIN SPECIMEN CONTAINER 180ML; FORMALIN, NEUTRAL BUFFERED

Lot Number	147858
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Cardinal health 180ml formalin containers leaking into specimen bags.Specimen containers are secured tightly.Leaking specimens pose a risk to patient safety (loss of specimen or degradation of specimen) and a safety risk to laboratory and transport personnel.No specimen loss has been reported.This facility has noted this concern with lot #s 147858 exp 10/2028, 221050 exp 2/29/2028, and 217915 exp 1/31/2028.Reference reports: mw5169125, mw5169126.

• Brand Name: PREFILLED FORMALIN SPECIMEN CONTAINER 180ML
• Common Device Name: FORMALIN, NEUTRAL BUFFERED
• Manufacturer (Section D): CARDINAL HEALTH; 7000 cardinal place; dublin OH 43017
• MDR Report Key: 21850269
• Report Number: MW5169124
• Device Sequence Number: 18013603
• Product Code: IFP
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/11/2025

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 Lot Number: 147858
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/16/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown