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 04/13/2022

Event Type  malfunction  

Event Description

Statlab 20ml formalin container lid cracked tissue present in container and test was able to run.Manufacturer response for formalin container, (brand not provided) (per site reporter).We have filed multiple complaints to medsun and to the manufacturer.We have provided them a sample of the cracked lids.

• 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: 14205561
• MDR Text Key: 290064543
• Report Number: 14205561
• 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: 04/18/2022

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/18/2022
• Event Location: Hospital
• Date Report to Manufacturer: 04/26/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/26/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1