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

Catalog Number NB0507

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 03/22/2022

Event Type  No Answer Provided  

Event Description

Cracked lid leading to leaking of specimen.

• Brand Name: FORMALIN
• Type of Device: FORMALIN, NEUTRAL BUFFERED
• Manufacturer (Section D): SLMP LLC (STATLAB MEDICAL PRODUCTS); 2090 commerce dr; mckinney TX 75069
• MDR Report Key: 14102263
• MDR Text Key: 289183587
• Report Number: 14102263
• Device Sequence Number: 1
• Product Code: IFP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/31/2022

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?: No
• Device Catalogue Number: NB0507
• Device Lot Number: 138192
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/31/2022
• Date Report to Manufacturer: 04/13/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/13/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1