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

Catalog Number NB0507

Device Problem Crack (1135)

Patient Problem Insufficient Information (4580)

Event Date 03/15/2022

Event Type  malfunction  

Event Description

20 ml statlab formalin container lid cracked.Container delivered from westerly urology to westerly hospital histology department.Specimen present in container and test able to be run on sample.

• 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: 14083799
• MDR Text Key: 289091496
• Report Number: 14083799
• 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?: Yes
• Device Catalogue Number: NB0507
• 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
• Event Location: Hospital
• Date Report to Manufacturer: 04/12/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1