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

Catalog Number NB0507

Device Problem Crack (1135)

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

Event Date 02/14/2022

Event Type  malfunction  

Event Description

Statlab 20 ml formalin containers have a crack in the lid for two separate patients.Pathology tests were able to be performed and no harm to patients occurred.I do not know if it was product related or user closed the lid too tight.Specimen part a small bowel biopsy specimen part d gastric polyp.

• Brand Name: FORMALIN
• Type of Device: FORMALIN, NEUTRAL BUFFERED
• Manufacturer (Section D): SLMP LLC (STATLAB MEDICAL PRODUCTS); 2090 commerce drive; mckinney TX 75069
• MDR Report Key: 14083549
• MDR Text Key: 289073576
• Report Number: 14083549
• 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: 04/05/2022

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: 04/05/2022
• 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