MAUDE Adverse Event Report: STATLAB MEDICAL PRODUCTS/SLMP LLC (STATLAB MEDICAL PRODUCTS) STATLAB SPECIMEN TRANSPORT CONTAINER; FORMALIN, NEUTRAL BUFFERED

Model Number CH60NBFBJC

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2023

Event Type  Injury  

Event Description

Several instances of the fluid inside the cup leaking out after closing.The cup lid "clicks" when closing to indicate it has sealed.Discovered multiple cups not clicking when closing.Not all the cups that did not "click" when closed leaked, but all the cups that leaked did not "click".Reference report: mw5149505.

• Brand Name: STATLAB SPECIMEN TRANSPORT CONTAINER
• Type of Device: FORMALIN, NEUTRAL BUFFERED
• Manufacturer (Section D): STATLAB MEDICAL PRODUCTS/SLMP LLC (STATLAB MEDICAL PRODUCTS); mckinney TX 75069
• MDR Report Key: 18392479
• MDR Text Key: 331437566
• Report Number: MW5149506
• Device Sequence Number: 1
• Product Code: IFP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/20/2023

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
• Device Operator: Health Professional
• Device Model Number: CH60NBFBJC
• Device Catalogue Number: CH60NBF
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 68 KG
• Patient Race: White